RESUMEN
INTRODUCTION: Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice. METHODS: The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication. DISCUSSION: This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias. TRIAL REGISTRATION: ISRCTN 14729158. Registered on 02 May 2017.
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Procedimientos Quirúrgicos del Sistema Digestivo , Fluidoterapia , Laparotomía , Anciano , Humanos , Persona de Mediana Edad , Gasto Cardíaco , Fluidoterapia/métodos , Hemodinámica , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Abstract Background: Hemodilution, transoperative bleeding and cardiopulmonary bypass (CPB) are some of the factors associated with high transfusion rates in cardiac surgery. Objective: To analyze the incidence of blood transfusion and early postoperative outcomes in cardiac surgery patients. Methods: Cohort study of patients undergoing cardiac surgery in a university hospital, consecutively enrolled from May 2015 to February 2017. Data were prospectively collected and comparisons were made between two patients' groups: transfused and not transfused. Student's t-test, chi-square test, and logistic regression were used, and a p-value < 0.05 was considered significant. Results: Among the 271 patients evaluated, 100 (37%) required transfusion in the transoperative (32.1%) and/or postoperative periods (19.5%). The following predictors of transfusion were identified by multivariate analysis: EuroScore II (OR 1.2); chronic kidney disease (CKD) (OR 3.2); transoperative bleeding ≥ 500 mL (OR 6.7); baseline hemoglobin (Hb) ≤ 10 g/dL (OR 11.5); activated partial thromboplastin time (aPTT) (OR 1.1) and CPB duration (OR 1.03). Transfusion was associated with prolonged mechanical ventilation (≥ 24h) (2.4% vs. 23%), delirium (5.9% vs. 18%), bronchopneumonia (1.2% vs. 16%), acute renal failure (3.5% vs. 25%), acute on CKD (0.6% vs. 8%), stroke or transient ischemic attack (1.8% vs. 8%), intensive care unit stay ≥ 72 h (36% vs. 57%), longer hospital stay (8 ± 4 days vs. 16 ± 15 days), as well as increased early mortality (1.75% vs. 15%). Conclusion: EuroScore II, CKD, major transoperative bleeding, preoperative Hb and aPTT values and CPB time were independent predictors of transfusion, which was associated with a higher rate of adverse outcomes, including early mortality.
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Humanos , Masculino , Persona de Mediana Edad , Anciano , Complicaciones Posoperatorias/prevención & control , Transfusión Sanguínea/estadística & datos numéricos , Cuidados Intraoperatorios/efectos adversos , Estudios Prospectivos , Factores de Riesgo , Medición de Riesgo , Procedimientos Quirúrgicos Torácicos , Reacción a la TransfusiónRESUMEN
PURPOSE: To evaluate the benefit of an antimicrobial prophylaxis protocol using rectal swab cultures in patients undergoing transrectal ultrasound (TRUS)-guided prostate biopsy in our Veterans Affairs population. METHODS: Between June 1, 2013, and June 1, 2014, we implemented an antimicrobial prophylaxis protocol using rectal swab cultures on selective media containing ciprofloxacin for all men scheduled for TRUS-guided prostate biopsy. Data from 2759 patients from Jan 1, 2006 to May 31, 2013, before protocol implementation served as historical controls. Patients with fluoroquinolone (FQ)-susceptible organisms received FQ monotherapy, while those with FQ-resistant organisms received targeted prophylaxis. Our objective was to compare the rate of infectious complications 30 days after prostate biopsy before and after implementation of our antimicrobial protocol. RESULTS: One hundred and sixty-seven patients received rectal swab cultures using our protocol. Seventeen (14 %) patients had FQ-resistant positive cultures. Patients with positive FQ-resistant culture results were more likely to have had a history of previous prostate biopsy and a positive urine culture in the last 12 months (p = 0.032, p = 0.018, respectively). The average annual infectious complication rate within 30 days of biopsy was reduced from 2.8 to 0.6 % before and after implementation of our antimicrobial prophylaxis protocol using rectal swab cultures, although this difference was not statistically significant (p = 0.13). CONCLUSION: An antimicrobial prophylaxis protocol using rectal culture swabs is a viable option for prevention of TRUS-guided prostate biopsy infectious complications. After implementation of an antimicrobial prophylaxis protocol, we observed a nonsignificant decrease in the rate of post-biopsy infectious complications when compared to historical controls.