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INTRODUCTION: Metformin is a first-line antihyperglycaemic agent for type 2 diabetes (T2DM). In addition to glycaemic control, it offers benefits related to cardiovascular health, weight neutrality and metabolic syndrome. However, its benefits in kidney transplant recipients remain unclear as metformin use is controversial in this population due to a lack of evidence and there are recommendations against its use in patients with poor kidney function. Hence, we seek to describe a protocol for a systematic review, which will assess the impact of metformin use on graft survival and mortality in kidney transplant recipients. METHODS: This protocol was guided by the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015. We will search empirical databases such as MEDLINE, Embase, Cochrane Library, CINAHL and Web of Science Core Collection for relevant studies conducted in kidney transplant recipients using metformin, which report outcomes related to graft and patient survival. All studies meeting these criteria in adults and published in English from inception to 2023 will be included in our review. We will employ the Cochrane Risk of Bias Tool 2 for randomised controlled trials and the Risk of Bias in Non-randomised Studies of Intervention for non-randomised studies. We will present our data and study characteristics in a table format and determine if a meta-analysis can be performed by clinical and methodological heterogeneity, using the I2 statistics. If a meta-analysis cannot be performed, we will provide a narrative synthesis of included studies using the Synthesis Without Meta-Analysis Reporting Guideline. ETHICS AND DISSEMINATION: Ethical approval will not be required for this review as the data used will be extracted from already published studies with publicly accessible data. As this study will assess the impact of metformin use on graft and patient survival in kidney transplant recipients, evidence gathered through it will be disseminated using traditional approaches that include open-access peer-reviewed publication, scientific presentations and a report. We will also disseminate our findings to appropriate academic bodies in charge of publishing guidelines related to T2DM and transplantation, as well as patient and research centred groups. PROSPERO REGISTRATION NUMBER: CRD42023421799.
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Diabetes Mellitus Tipo 2 , Supervivencia de Injerto , Hipoglucemiantes , Trasplante de Riñón , Metformina , Revisiones Sistemáticas como Asunto , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/mortalidad , Metformina/uso terapéutico , Supervivencia de Injerto/efectos de los fármacos , Hipoglucemiantes/uso terapéutico , Proyectos de Investigación , Receptores de TrasplantesRESUMEN
OBJECTIVES: Identify the windows of opportunity for the diagnosis of chronic kidney disease (CKD) and the prevention of its adverse outcomes and quantify the potential population gains of such prevention. DESIGN AND SETTING: Observational, population-wide study of residents in the Stockholm and Skåne regions of Sweden between 1 January 2015 and 31 December 2020. PARTICIPANTS: All patients who did not yet have a diagnosis of CKD in healthcare but had CKD according to laboratory measurements of CKD biomarkers available in electronic health records. OUTCOME MEASURES: We assessed the proportions of the patient population that received a subsequent diagnosis of CKD in healthcare, that used guideline-directed pharmacological therapy (statins, renin-angiotensin aldosterone system inhibitors (RAASi) and/or sodium-glucose cotransporter-2 inhibitors (SGLT2i)) and that experienced adverse outcomes (all-cause mortality, cardiovascular mortality or major adverse cardiovascular events (MACE)). The potential to prevent adverse outcomes in CKD was assessed using simulations of guideline-directed pharmacological therapy in untreated subsets of the study population. RESULTS: We identified 99 382 patients with undiagnosed CKD during the study period. Only 33% of those received a subsequent diagnosis of CKD in healthcare after 5 years. The proportion that used statins or RAASi was of similar size to the proportion that didn't, regardless of how advanced their CKD was. The use of SGLT2i was negligible. In simulations of optimal treatment, 22% of the 21 870 deaths, 27% of the 14 310 cardiovascular deaths and 39% of the 22 224 MACE could have been avoided if every patient who did not use an indicated medication for their laboratory-confirmed CKD was treated with guideline-directed pharmacological therapy for CKD. CONCLUSIONS: While we noted underdiagnosis and undertreatment of CKD in this large contemporary population, we also identified a substantial realisable potential to improve CKD outcomes and reduce its burden by treating patients early with guideline-directed pharmacological therapy.
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Inhibidores de Hidroximetilglutaril-CoA Reductasas , Insuficiencia Renal Crónica , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Estudios de Cohortes , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Insuficiencia Renal Crónica/terapiaRESUMEN
OBJECTIVES: To study the association between risk for hospitalisation in an elderly population related to renal function, number of chronic diseases and number of prescribed drugs. DESIGN: A case-control study. Persons hospitalised were included and their controls were obtained from electronic hospital medical records. If data were lacking on creatinine levels, multiple imputation was used. SETTING: Blekinge County in southwestern Sweden. PARTICIPANTS: Study of individuals aged 75 years or older in 2013. We identified a total of 2,941 patients with a first hospitalisation. Of these, 81 were excluded, 78 due to incomplete data and 3 because of lack of control persons. Controls were matched to the same sex and birth year, which resulted in 5720 persons. PRIMARY AND SECONDARY OUTCOME MEASURES: To analyse the OR for hospitalisation conditional logistic regression was used. RESULTS: A total of 695 persons lacked creatinine value. Using imputation values comparing persons with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 with ≥30 univariate analyses showed an increased OR 2.35 (95% CI 1.83 to 3.03). Adjusted analyses demonstrated an OR of 1.90 (95% CI 1.46 to 2.47). Comparing eGFR<45 mL/min/1.73 m2 against ≥45 univariate analyses showed OR 1.38 (95% CI 1.22 to 1.57). Adjusted analyses OR for the same group were 1.17 (95% CI 1.03 to 1.33). In both models, the OR for five or more chronic conditions and five or more medications showed a statistically increased risk for hospitalisation. CONCLUSIONS: There is a need for systems using data collected in routine care to follow elderly patients to minimise avoidable hospitalisations that can cause adverse effects. Renal function, number of chronic conditions and medications are factors that are of significant importance. This study demonstrates the complexity of this patient group.
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Hospitalización , Riñón , Humanos , Anciano , Estudios de Casos y Controles , Creatinina , Suecia/epidemiología , Enfermedad CrónicaRESUMEN
OBJECTIVE: Evidence related to the risk of kidney damage by proton pump inhibitor (PPI) initiation in patients with 'underlying' chronic kidney disease (CKD) remains scarce, although PPI use is generally associated with acute interstitial nephritis or incident CKD. We aimed to investigate the association between PPI initiation and the risk of adverse outcomes in patients with CKD in the absence of any deterministic indications for PPI usage. DESIGN: Retrospective observational study. SETTING: Korea National Health Insurance Service database from 2009 to 2017. PARTICIPANTS: A retrospective cohort of new PPI and histamine H2-receptor antagonists (H2RA) users among people with CKD. Patients with a history of gastrointestinal bleeding or those who had an endoscopic or image-based upper gastrointestinal tract evaluation were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: The study subjects were followed to ascertain clinical outcomes including mortality, end-stage kidney disease (ESKD), myocardial infarction and stroke. The HRs of outcomes were measured using a Cox regression model after adjusting for multiple variables. We applied an inverse probability of treatment weighting (IPTW) model to control for residual confounders. RESULTS: We included a total of 1038 PPI and 3090 H2RA users without deterministic indications for treatment. IPTW-weighted Cox regression analysis showed that PPI initiation was more significantly associated with a higher ESKD risk compared with that of H2RA initiation (adjusted HR 1.72 (95% CI 1.19 to 2.48)), whereas the risks of mortality or cardiovascular outcomes were similar between the two groups. In the subgroup analysis, multivariable Cox regression analysis showed that the association between PPI use and the progression to ESKD remained significant in non-diabetic and low estimated glomerular filtration rate (<60 mL/min/1.73 m2) groups (adjusted HR 1.72 (95% CI 1.19 to 2.48) and 1.63 (95% CI 1.09 to 2.43), respectively). CONCLUSIONS: Initiation of PPI administration may not be recommended in patients with CKD without deterministic indication, as their usage was associated with a higher risk of ESKD.
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Fallo Renal Crónico , Insuficiencia Renal Crónica , Humanos , Estudios de Cohortes , Estudios Retrospectivos , Inhibidores de la Bomba de Protones/efectos adversos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/tratamiento farmacológico , Fallo Renal Crónico/epidemiología , Fallo Renal Crónico/complicaciones , Factores de RiesgoRESUMEN
OBJECTIVE: To determine the prevalence of uncontrolled hypertension and its associated factors among patients with early chronic kidney disease (CKD) attending medical outpatient clinics at tertiary hospitals in Dodoma, Tanzania. DESIGN: Cross-sectional study. SETTING: Two tertiary hospitals in Dodoma, Tanzania. PARTICIPANTS: The participants in this study were adult patients (≥18 years) with early CKD stages (1, 2 and 3) who were attending nephrology and medical outpatient clinics from November 2020 to March 2021. Patients who had been attending the clinic for at least 3 months, had baseline clinical data on their files, had estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and who provided written informed consent were eligible. A total of 352 patients were enrolled, of whom 182 were men and 170 were women. OUTCOME MEASURE: The dependent variable was uncontrolled hypertension among patients with early CKD, based on blood pressure measurements. RESULTS: The prevalence of hypertension was 58.5% (206 of 352) and the prevalence of uncontrolled hypertension was 58.3% (120 of 206). Among patients with uncontrolled hypertension, 88.3% (106 of 120) had CKD stage 3, 80.2% (96 of 120) reported non-adherence to antihypertensives, 76.7% (92 of 120) were overweight or obese, 72.5% (87 of 120) reported current alcohol use and 26.7% (32 of 120) had diabetes mellitus. Factors that contributed to higher odds of uncontrolled hypertension were: age ≥50 years (OR=5.17, 95 % CI 2.37 to 13.33, p=0.001), alcohol use (OR=11.21, 95% CI 3.83 to 32.84, p=0.001), non-adherence to antihypertensives (OR=10.19, 95% CI 4.22 to 24.61, p=0.001), overweight/obesity (OR=6.28, 95% CI 2.54 to 15.53, p=0.001) and CKD stage 3 (OR=3.52, 95% CI 1.32 to 9.42, p=0.012). CONCLUSION: Uncontrolled hypertension was highly prevalent among patients with early CKD in this setting and was associated with age, current alcohol use, non-adherence to antihypertensives, overweight/obesity and declining eGFR.
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Hipertensión , Insuficiencia Renal Crónica , Adulto , Masculino , Humanos , Femenino , Persona de Mediana Edad , Estudios Transversales , Antihipertensivos/uso terapéutico , Sobrepeso/complicaciones , Centros de Atención Terciaria , Prevalencia , Tanzanía/epidemiología , Hipertensión/complicaciones , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Obesidad/complicaciones , Obesidad/epidemiología , Obesidad/tratamiento farmacológico , Factores de Riesgo , Tasa de Filtración Glomerular/fisiologíaRESUMEN
OBJECTIVES: Kidney transplantation offers patients better quality of life and survival compared with dialysis. The risk of end stage renal disease is higher among ethnic minorities and they experience longer wait times on transplant lists. This inequality stems from a high need for kidney transplantation combined with a low rate of deceased donation among ethnic minority groups. This study aimed to explore the perspectives around living donor kidney transplantation of members of the Sikh and Muslim communities with an aim to develop a digital intervention to overcome any barriers. DESIGN: A qualitative descriptive study using in person focus groups. SETTING: University Teaching Hospital and Transplant Centre. PARTICIPANTS: Convenience sampling of participants from the transplant population. Three focus groups were held with 20 participants, all were of South Asian ethnicity belonging to the Sikh and Muslim communities. METHODS: Interviews were digitally audio-recorded and transcribed verbatim; transcripts were analysed thematically. RESULTS: Four themes were identified: (a) religious issues; (b) lack of knowledge within the community; (c) time; (d) cultural identification with transplantation. CONCLUSIONS: Not only is the information given and when it is delivered important, but also the person giving the information is crucial to enhance consideration of live donor kidney transplantation. Information should be in a first language where possible and overtly align to religious considerations. A more integrated approach to transplantation counselling should be adopted which includes healthcare professionals and credible members of the target cultural group. TRIAL REGISTRATION NUMBER: NCT04327167.
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Fallo Renal Crónico , Trasplante de Riñón , Humanos , Diálisis Renal , Islamismo , Etnicidad , Calidad de Vida , Grupos Minoritarios , Fallo Renal Crónico/cirugíaRESUMEN
OBJECTIVE: To investigate the relationship between alcohol consumption and hyperuricaemia (HUA), we conducted a study based on a large population. SETTING: Cross-sectional study. PARTICIPANTS: A total of 20 833 participants aged 30-79 years were enrolled in the China Multi-Ethnic Cohort, Chongqing region. OUTCOMES: The serum level of uric acid, fasting blood glucose and blood lipids were tested. Basic demographic statistics such as age, gender, marital status, education level, family annual income and the detail information of alcohol consumption were collected using a standardised questionnaire. RESULTS: After controlling for potential confounders, compared with participants who never consumed alcohol, participants who drank 3-5 days per week had the highest risk of HUA (OR: 1.51, 95% CI: 1.25 to 1.82) and those who drank alcohol harmfully had the highest risk of HUA (OR: 1.81, 95% CI: 1.41 to 2.32). In addition, we found that those who drank moderately had no significant association with risk of HUA. However, among men, compared with participants who never consumed alcohol, those who drank moderately was also a risk factor of HUA (OR: 1.23, 95% CI: 1.03 to 1.46) and those who drank alcohol harmfully had the highest risk of HUA (OR: 2.13, 95% CI: 1.64 to 2.78). Compared with participants who drank alcohol moderately, the OR (95% CI) for those who drank alcohol harmfully had the highest risk of HUA was 1.88 (1.42 to 2.48), and the corresponding OR (95% CI) for each level increment in the degree of alcohol consumption was 1.22 (1.12 to 1.33). Among men, compared with participants who drank alcohol moderately, those who drank alcohol harmfully had the highest risk of HUA (OR: 1.93, 95% CI: 1.45 to 2.57), as well as the corresponding OR (95% CI) for each level increment in the degree of alcohol consumption was 1.24 (1.13 to 1.35). CONCLUSION: This study suggested that the frequency and degree of alcohol consumption may be the risk factors for HUA, especially in males.
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Hiperuricemia , Adulto , Masculino , Humanos , Estudios Transversales , Hiperuricemia/epidemiología , Consumo de Bebidas Alcohólicas/efectos adversos , Consumo de Bebidas Alcohólicas/epidemiología , Factores de Riesgo , China/epidemiología , EtanolRESUMEN
OBJECTIVES: Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions. DESIGN: A cross-sectional study conducted from September 2017 to March 2018. SETTING: 48 residential elderly care facilities in northern China. PARTICIPANTS: Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia. EXPOSURE: Potassium intake is measured by 24-hour urinary potassium. OUTCOMES: Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect. RESULTS: Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted ß=0.0040/L; p=0.017) and high (adjusted ß=0.0078/L; p=0.003) but not low (adjusted ß=0.0018/L; p=0.311) risk of hyperkalaemia. CONCLUSIONS: A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns. TRIAL REGISTRATION NUMBER: NCT03290716; Post-results.
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Hiperpotasemia , Masculino , Humanos , Anciano , Femenino , Estudios Transversales , Hiperpotasemia/epidemiología , Potasio en la Dieta , Pueblos del Este de Asia , PotasioRESUMEN
OBJECTIVE: There are several equations for estimating the glomerular filtration rate (GFR), and each method has its limitations. We compared various estimated GFR (eGFR) equations with 24 hours urine creatinine clearance (24u-CCr). DESIGN: Sample analysis of randomised controlled trial participants. SETTING AND PARTICIPANTS: We compared the mean 24u-CCr values measured 2-3 times for 211 patients with eGFR values calculated using the following equations: isotope dilution mass spectrometry-Modification of Diet in Renal Disease (IDMS-MDRD) equation, Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, equations for Koreans (KOR-IDMS-MDRD and KOR-CKD-EPI) and full age spectrum equation. OUTCOME MEASURES: Performance of various creatinine-based eGFR equations, including those with Korean coefficients, compared with the results of the 24u-CCr. RESULTS: IDMS-MDRD showed the best overall correlation with the 24u-CCr (R=0.949, p<0.001), and KOR-CKD-EPI showed the best agreement in terms of the intraclass correlation coefficient (ICC, 0.969, 95% CI 0.959 to 0.976, p<0.001). In subgroup analysis, IDMS-MDRD-GFR showed the highest ICCs in CKD stages 1 and 3 (ICC 0.872 in stage 1 and 0.927 in CKD stage 3, all p<0.001). KOR-CKD-EPI showed the highest ICC in CKD stage 2 (ICC 0.854, p<0.001). Overall, the accuracy of CKD-EPI (2021) was the highest at P15 (15%) and P30 (30%) (P15: 65.4 and P30: 97.6). In addition, CKD-EPI (2021) showed the highest P30 accuracy in CKD stage 1 (98.7), whereas KOR-IDMS-MDRD showed the highest P30 accuracy in CKD stages 2 and 3 (98.8 and 98.2, respectively). CONCLUSIONS: The IDMS-MDRD equation showed the best correlation and overall good agreement with the 24u-CCr; however, the accuracy was low. The most accurate measurements were obtained using the CKD-EPI (2021) equation in CKD stage 1 and the KOR-IDMS-MDRD equation in CKD stages 2-3; nevertheless, the CKD-EPI (2021) equation showed the best overall accuracy. TRIAL REGISTRATION NUMBER: NCT01552954.
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Líquidos Corporales , Insuficiencia Renal Crónica , Humanos , Tasa de Filtración Glomerular , Creatinina , UrinálisisRESUMEN
INTRODUCTION: Living donor (LD) kidney transplant (KT) is the best treatment option for many patients with kidney failure as it improves quality of life and survival compared with dialysis and deceased donor KT. Unfortunately, LDKT is underused, especially among groups marginalised by race and ethnicity. African, Caribbean and Black (ACB) patients are 60%-70% less likely to receive LDKT in Canada compared with white patients. Research from the USA and the UK suggests that mistrust, cultural and generational norms, access, and affordability may contribute to inequities. To date, no Canadian studies have explored the beliefs and behaviours related to LDKT in ACB communities. Research approaches that use a critical, community-based approach can help illuminate broader structural factors that may shape individual beliefs and behaviours. In this qualitative study, we will investigate barriers to accessing LDKT in ACB communities in the Greater Toronto Area, to enhance our understanding of the perspectives and experiences of ACB community members, both with and without lived experience of chronic kidney disease (CKD). METHODS AND ANALYSIS: Hospital-based and community-based recruitment strategies will be used to recruit participants for focus groups and individual interviews. Participants will include self-identified ACB individuals with and without experiences of CKD and nephrology professionals. Collaboration with ACB community partners will facilitate a community-based research approach. Data will be analysed using reflexive thematic analysis and critical race theory. Findings will be revised based on feedback from ACB community partners. ETHICS AND DISSEMINATION: This study has been approved by the University Health Network Research Ethics Board UHN REB file #15-9775. Study findings will contribute to the codevelopment of culturally safe and responsive educational materials to raise awareness about CKD and its treatments and to improve equitable access to high-quality kidney care, including LDKT, for ACB patients.
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Disparidades en Atención de Salud , Trasplante de Riñón , Donadores Vivos , Insuficiencia Renal Crónica , Adulto , Femenino , Humanos , Masculino , Pueblo Africano/estadística & datos numéricos , Población Negra/estadística & datos numéricos , Pueblos Caribeños/estadística & datos numéricos , Disparidades en Atención de Salud/etnología , Disparidades en Atención de Salud/estadística & datos numéricos , Trasplante de Riñón/estadística & datos numéricos , Ontario , Investigación Cualitativa , Insuficiencia Renal Crónica/etnología , Insuficiencia Renal Crónica/terapiaRESUMEN
OBJECTIVES: REVEAL-CKD aims to estimate the prevalence of, and factors associated with, undiagnosed stage 3 chronic kidney disease (CKD). DESIGN: Multinational, observational study. SETTING: Data from six country-specific electronic medical records and/or insurance claims databases from five countries (France, Germany, Italy, Japan and the USA [two databases]). PARTICIPANTS: Eligible participants (≥18 years old) had ≥2 consecutive estimated glomerular filtration rate (eGFR) measurements (calculated from serum creatinine values, sex and age) taken from 2015 onwards that were indicative of stage 3 CKD (≥30 and <60 mL/min/1.73 m2). Undiagnosed cases lacked an International Classification of Diseases 9/10 diagnosis code for CKD (any stage) any time before, and up to 6 months after, the second qualifying eGFR measurement (study index). MAIN OUTCOME MEASURES: The primary outcome was point prevalence of undiagnosed stage 3 CKD. Time to diagnosis was assessed using the Kaplan-Meier approach. Factors associated with lacking a CKD diagnosis and risk of diagnostic delay were assessed using logistic regression adjusted for baseline covariates. RESULTS: The prevalence of undiagnosed stage 3 CKD was 95.5% (19 120/20 012 patients) in France, 84.3% (22 557/26 767) in Germany, 77.0% (50 547/65 676) in Italy, 92.1% (83 693/90 902) in Japan, 61.6% (13 845/22 470) in the US Explorys Linked Claims and Electronic Medical Records Data database and 64.3% (161 254/250 879) in the US TriNetX database. The prevalence of undiagnosed CKD increased with age. Factors associated with undiagnosed CKD were female sex (vs male, range of odds ratios across countries: 1.29-1.77), stage 3a CKD (vs 3b, 1.81-3.66), no medical history (vs a history) of diabetes (1.26-2.77) or hypertension (1.35-1.78). CONCLUSIONS: There are substantial opportunities to improve stage 3 CKD diagnosis, particularly in female patients and older patients. The low diagnosis rates in patients with comorbidities that put them at risk of disease progression and complications require attention. TRIAL REGISTRATION: NCT04847531.
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Diagnóstico Tardío , Insuficiencia Renal Crónica , Humanos , Masculino , Femenino , Adolescente , Prevalencia , Japón/epidemiología , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/complicaciones , Progresión de la Enfermedad , Tasa de Filtración Glomerular , Factores de RiesgoRESUMEN
INTRODUCTION: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients. METHODS AND ANALYSIS: KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion. TRIAL REGISTRATION NUMBER: NCT04040296.
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Lesión Renal Aguda , COVID-19 , Humanos , SARS-CoV-2 , Diálisis Renal , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/terapia , Riñón , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
INTRODUCTION: Hyperkalaemia (HK) is a potentially life-threatening electrolyte imbalance associated with several adverse clinical outcomes. The efficacy and negative effects of currently existing treatment options have made HK management questionable. Sodium zirconium cyclosilicate (SZC), a novel highly selective potassium binder, is approved for the treatment of HK. The present study will be aimed to assess the safety, effectiveness and treatment patterns of SZC in Chinese patients with HK in a real-world clinical setting as it is required by China's drug review and approval process. METHODS AND ANALYSIS: This is a multicentre, prospective cohort study which plans to enrol 1000 patients taking SZC or willing to take SZC from approximately 40 sites in China. Patients ≥18 years of age at the time of signing the written informed consent and with documented serum potassium levels ≥5.0 mmol/L within 1 year before study enrolment day will be included. Eligible patients will receive SZC treatment and will be followed up for 6 months from enrolment day. The primary objective will be to evaluate the safety of SZC for the management of HK in Chinese patients in terms of adverse events (AEs), serious AEs as well as discontinuation of SZC. The secondary objectives will include understanding the SZC dosage information in terms of its effectiveness and treatment patterns under real-world clinical practice and assessing effectiveness of SZC during the observational period. ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University (approval number: YJ-JG-YW-2020). All the participating sites have received the ethics approval. Results will be disseminated through national and international presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05271266.
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Hiperpotasemia , Humanos , China , Hiperpotasemia/tratamiento farmacológico , Potasio , Estudios Prospectivos , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVES: To describe prevalence of chronic kidney disease (CKD), demographic and clinical characteristics, treatment patterns and rates of cardiovascular and renal complications for patients with type 2 diabetes (T2D) treated in routine clinical care. DESIGN: Repeat cross-sectional study (6 monthly cross-sections) and cohort study from 1 January 2017 to 31 December 2019. SETTING: Primary care data from English practices contributing to the UK Clinical Practice Research Datalink linked to Hospital Episode Statistics and Office for National Statistics mortality data. PARTICIPANTS: Patients with T2D aged >18 years, at least one year of registration data. PRIMARY AND SECONDARY OUTCOMES: Primary outcome was prevalence of CKD defined as chronic kidney disease epidemiology collaboration (CKD-EPI) estimated glomerular filtration rate <60 mL/min/1.73 m2, and/or urinary albumin creatinine ratio ≥3 mg/mmol in the past 24 months. Secondary outcomes were prescriptions of medications of interest and clinical and demographic characteristics in the past 3 months.In the cohort study rates of renal and cardiovascular complications, all-cause mortality and hospitalisations over the study period were compared among those with and without CKD. RESULTS: There were 574 190 eligible patients with T2D as of 1 January 2017 and 664 296 as of 31 December 2019. Estimated prevalence of CKD across the study period was stable at approximately 30%. Medication use was stable over time in people with CKD and T2D, with low use of steroidal mineralocorticoid receptor antagonists (approximately 4.5% across all time points) and a low use but steady increase in use of sodium-glucose co-transporter-2 inhibitors (from 2.6% to 6.2%). Rates of all complications were higher in those with CKD at the start of the study period, with increasing rates, with increased severity of CKD, heart failure and albuminuria. CONCLUSIONS: The burden of CKD in patients with T2D is high and associated with substantially increased rates of complications particularly in those with comorbid heart failure.
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Diabetes Mellitus Tipo 2 , Insuficiencia Cardíaca , Insuficiencia Renal Crónica , Humanos , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Estudios de Cohortes , Estudios Transversales , Insuficiencia Renal Crónica/epidemiología , Inglaterra/epidemiologíaRESUMEN
INTRODUCTION: Hyperuricaemia has been implicated in the development of kidney function in populations with chronic kidney disease; however, the benefits of urate-lowering therapy (ULT) remain uncertain in different clinical studies. The different kidney functions of enrolled populations and distinct pharmacokinetic characteristics of ULT might be of the essence for the contrasting results. In this study, we will synthesise all available data from randomised controlled trials (RCTs) and cohort studies, then evaluate the outcomes of ULT in patients stratified by different estimated glomerular filtration rate (eGFR) stratifications. Furthermore, we will attempt to explore a relatively optimal ULT regimen using a Bayesian network meta-analysis in different eGFRs. METHODS AND ANALYSIS: We searched published and unpublished data from MEDLINE, EMBASE, the Cochrane Central Register of Controlled trials and ClinicalTrials.gov website (before March 2022) for RCTs and cohort studies without language restriction. In the pairwise meta-analysis, all regimens of ULT will be pooled as a whole and compared with controls in different eGFRs. The random-effects model will be applied to generate the summary values using the software Stata V.12.0 (StataCorp). Network meta-analysis within a Bayesian framework will be conducted to explore the relative efficacy profiles of different ULTs and to find optimal ULT in different eGFRs. The software of WinBUGS V.1.4.3 and R2WinBUGS package of R V.3.1.1 will be used in the network meta-analysis. Primary outcomes will be the occurrence of major cardiovascular events and kidney failure events. Secondary outcomes will include the rate of change in eGFR per year, all-cause death, changes in serum uric acid level and major adverse events. Two authors will independently review study selection, data extraction and quality assessment. ETHICS AND DISSEMINATION: The meta-analysis does not require ethical certification. The results will be disseminated through publication in a peer-reviewed journal and through presentations at academic conferences. PROSPERO REGISTRATION NUMBER: CRD42021226163.
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Hiperuricemia , Insuficiencia Renal Crónica , Humanos , Ácido Úrico , Metaanálisis en Red , Insuficiencia Renal Crónica/tratamiento farmacológico , Hiperuricemia/tratamiento farmacológico , Riñón , Ensayos Clínicos Controlados Aleatorios como Asunto , Metaanálisis como AsuntoRESUMEN
OBJECTIVES: The treatment workload associated with end-stage kidney disease (ESKD) is high. The treatment burdens experienced by patients with ESKD are not well understood. In this study, we aimed to elucidate the most important areas of treatment burden for discussion in a clinical encounter from the perspectives of patients with ESKD and nephrologists. We sought to explore possible solutions to these high priority treatment burden challenges. DESIGN: Nominal group technique (NGT) sessions. SETTING AND PARTICIPANTS: Three in-person NGT sessions were conducted with 19 patients with dialysis-dependent ESKD from one tertiary treatment centre (mean age 64 years; range 47-82). All patients were either retired or on a disability pension; 74% perceived moderate or severe treatment burden; and 90% spent more than 11 hours on treatment-related activities per week (range 11-30). One online NGT session was conducted with six nephrologists from two Australian states. MAIN OUTCOME MEASURES: The primary outcome was a ranked list of treatment burden priorities. The secondary outcome was potential solutions to these treatment burden challenges. RESULTS: Every patient group ranked health system issues as the most important treatment burden priority. This encompassed lack of continuity and coordination of care, dissatisfaction with frequent healthcare encounters and challenges around healthcare access. Psychosocial burdens on patients and families were perceived to be the most important area of treatment burden by physicians, and were ranked the second highest priority by patients. CONCLUSIONS: Discussing treatment burden in a clinical encounter may lead to a better understanding of patients' capacity to cope with their treatment workload. This could facilitate tailored care, improve health outcomes, treatment sustainability and patients' overall quality of life.
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Fallo Renal Crónico , Médicos , Humanos , Persona de Mediana Edad , Diálisis Renal/métodos , Calidad de Vida , Australia , Fallo Renal Crónico/terapiaRESUMEN
INTRODUCTION: Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication. METHODS AND ANALYSIS: We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings. TRIAL REGISTRATION NUMBER: NCT04466865.
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Calidad de Vida , Insuficiencia Renal , Humanos , Anciano , Persona de Mediana Edad , Diálisis Renal , Cuidados Paliativos/métodos , Comunicación , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: Acute kidney injury (AKI) is a common and severe complication of community acquired infection, but data on impact in sub-Saharan Africa (SSA) are lacking. We determined prevalence, risk factors and outcomes of infection associated kidney disease in adults in Malawi. DESIGN: A prospective cohort study of adults admitted to hospital with infection, from February 2021 to June 2021, collecting demographic, clinical, laboratory and ultrasonography data. SETTING: Adults admitted to a regional hospital in Southern Region, Malawi. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were prevalence of kidney disease and mortality by Cox proportional hazard model. AKI was defined according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines. Secondary outcomes were risk factors for AKI identified by logistic regression and prevalence of chronic kidney disease at 3 months. RESULTS: We recruited 101 patients presenting to hospital with infection. Median age was 38 years (IQR: 29-48 years), 88 had known HIV status of which 53 (60%) were living with HIV, and of these 42 (79%) were receiving antiretroviral therapy. AKI was present in 33/101 at baseline, of which 18/33 (55%) cases were severe (KDIGO stage 3). At 3 months, 28/94 (30%) participants had died, while 7/61 (11%) of survivors had chronic kidney disease. AKI was associated with older age (age: 60 years vs 40 years, OR: 3.88, 95% CI 1.82 to 16.64), and HIV positivity (OR: 4.08, 95% CI 1.28 to 15.67). Living with HIV was independently associated with death (HR: 3.97, 95% CI 1.07 to 14.69). CONCLUSIONS: Kidney disease is common among hospitalised adults with infection in Malawi, with significant kidney impairment identified at 3 months. Our study highlights the difficulty in diagnosing acute and chronic kidney disease, and the need for more accurate methods than creatinine based estimated glomerular filtration rate (eGFR) equations for populations in Africa. Patients with kidney impairment identified in hospital should be prioritised for follow-up.
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Lesión Renal Aguda , Insuficiencia Renal Crónica , Adulto , Humanos , Persona de Mediana Edad , Prevalencia , Malaui/epidemiología , Estudios Prospectivos , Factores de Riesgo , Hospitales , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/etiología , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiologíaRESUMEN
OBJECTIVES: Trajectories of estimated glomerular filtration rate (eGFR) decline vary highly among patients with chronic kidney disease (CKD). It is clinically important to identify patients who have high risk for eGFR decline. We aimed to identify clusters of patients with extremely rapid eGFR decline and develop a prediction model using a machine learning approach. DESIGN: Retrospective single-centre cohort study. SETTINGS: Tertiary referral university hospital in Toyoake city, Japan. PARTICIPANTS: A total of 5657 patients with CKD with baseline eGFR of 30 mL/min/1.73 m2 and eGFR decline of ≥30% within 2 years. PRIMARY OUTCOME: Our main outcome was extremely rapid eGFR decline. To study-complicated eGFR behaviours, we first applied a variation of group-based trajectory model, which can find trajectory clusters according to the slope of eGFR decline. Our model identified high-level trajectory groups according to baseline eGFR values and simultaneous trajectory clusters. For each group, we developed prediction models that classified the steepest eGFR decline, defined as extremely rapid eGFR decline compared with others in the same group, where we used the random forest algorithm with clinical parameters. RESULTS: Our clustering model first identified three high-level groups according to the baseline eGFR (G1, high GFR, 99.7±19.0; G2, intermediate GFR, 62.9±10.3 and G3, low GFR, 43.7±7.8); our model simultaneously found three eGFR trajectory clusters for each group, resulting in nine clusters with different slopes of eGFR decline. The areas under the curve for classifying the extremely rapid eGFR declines in the G1, G2 and G3 groups were 0.69 (95% CI, 0.63 to 0.76), 0.71 (95% CI 0.69 to 0.74) and 0.79 (95% CI 0.75 to 0.83), respectively. The random forest model identified haemoglobin, albumin and C reactive protein as important characteristics. CONCLUSIONS: The random forest model could be useful in identifying patients with extremely rapid eGFR decline. TRIAL REGISTRATION: UMIN 000037476; This study was registered with the UMIN Clinical Trials Registry.
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Insuficiencia Renal Crónica , Estudios de Cohortes , Progresión de la Enfermedad , Tasa de Filtración Glomerular , Hospitales , Humanos , Japón/epidemiología , Aprendizaje Automático , Insuficiencia Renal Crónica/complicaciones , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVES: To determine the long-term survival rates and prognostic factors in kidney transplant (KT) recipients in Jakarta, Indonesia. DESIGN: Retrospective cohort study. SETTING: A KT centre in Jakarta. PARTICIPANTS: We enrolled 754 consecutive adult recipients who underwent KT between 2010 and 2020. MAIN OUTCOME MEASURES: Rates of 10-year patient, all-cause and death-censored graft survival and their prognostic factors in KT recipients. RESULTS: The 10-year patient survival, all-cause survival and death-censored graft survival rates of KT recipients were 74%, 68% and 81%, respectively. The prognostic factors for poor patient survival were a pretransplant dialysis duration>24 months (HR 1.64, 95% CI, 1.08 to 2.49; p=0.02), cardiovascular disease (HR 1.59, 95% CI, 1.11 to 2.31; p=0.01), delayed graft function (DGF) (HR 4.94, 95% CI, 2.76 to 8.82; p<0.001), post-transplant infection (HR 2.63, 95% CI, 1.56 to 4.43; p<0.001) and acute rejection (HR 2.49, 95% CI, 1.20 to 5.15; p=0.01). All-cause graft survival was prognosticated by a pretransplant dialysis duration>24 months (HR 1.74, 95% CI, 1.15 to 2.47; p=0.007), cardiovascular disease (HR 1.65, 95% CI, 1.18 to 2.33; p=0.004), DGF (HR 5.39, 95% CI, 3.13 to 9.28; p<0.001), post-transplant infection (HR 2.46, 95% CI, 1.05 to 4.02; p<0.001) and acute rejection (HR 4.18, 95% CI, 2.23 to 7.84; p<0.001). Factors associated with poor death-censored graft survival were a pretransplant dialysis duration >24 months (HR 2.19, 95% CI, 1.32 to 3.63; p=0.002), cardiovascular disease (HR 1.65, 95% CI, 1.02 to 2.68; p=0.04) and acute rejection (HR 5.52, 95% CI, 2.80 to 10.83; p<0.001). CONCLUSIONS: The survival rates of KT recipients are prognosticated by pretransplant dialysis duration, cardiovascular disease, DGF, post-transplant infection and acute rejection. Stricter eligibility criteria for recipients, more sensitive cross-match testing methods and better infection management strategies may be beneficial for improving the survival rates.