RESUMEN

PURPOSE: To achieve reductions in infusion time, infusion sites, and frequency, a prospective, open-label, multicenter, Phase 3 study evaluated the safety, efficacy, and tolerability of subcutaneous immunoglobulin (SCIG) 16.5% (Cutaquig®, Octapharma) at enhanced infusion regimens. METHODS: Three separate cohorts received SCIG 16.5% evaluating volume, rate, and frequency: Cohort 1) volume assessment/site: up to a maximum 100 mL/site; Cohort 2) infusion flow rate/site: up to a maximum of 100 mL/hr/site or the maximum flow rate achievable by the tubing; Cohort 3) infusion frequency: every other week at twice the patient's weekly dose. RESULTS: For Cohort 1 (n = 15), the maximum realized volume per site was 108 mL/site, exceeding the currently labeled (US) maximum (up to 40 mL/site for adults). In Cohort 2 (n = 15), the maximum realized infusion flow rate was 67.5 mL/hr/site which is also higher than the labeled (US) maximum (up to 52 mL/hr/site). In Cohort 3 (n = 34), the mean total trough levels for every other week dosing demonstrated equivalency to weekly dosing (p value = 0.0017). All regimens were well tolerated. There were no serious bacterial infections (SBIs). Most patients had mild (23.4%) or moderate (56.3%) adverse events. The majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens and reported that switching to SCIG 16.5% was easy. CONCLUSIONS: SCIG 16.5% (Cutaquig®), infusions are efficacious, safe, and well tolerated with reduced infusion time, fewer infusion sites, and reduced frequency. Further, the majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens.

Asunto(s)

RESUMEN

Introducción: La hemodiafiltración en línea post-dilucional es una variante de hemodiálisis que, según diferentes estudios puede aumentar la supervivencia de los pacientes. Inicialmente, y a diferencia de la hemodiálisis convencional, se utilizaban flujos de dializado muy elevados (hasta 700-800 ml/min); nuevos estudios cuestionaron la utilidad de elevar tanto este flujo en cuanto a eficacia depurativa.Objetivo:Analizar las diferencias producidas en Kt, Kt/V y volumen de infusión en esta técnica utilizando flujo de baño de diálisis a 600 ml/min y a 500 ml/min, así como evaluar la repercusión en el consumo de agua durante la sesión.Método:Se incluyeron 22 pacientes crónicos dializados con hemodiafiltración en línea post-dilucional en monitores Artis®. Se estudiaron 440 sesiones, 220 con cada flujo. Las variables estudiadas fueron edad, tiempo de permanencia en técnica, Kt, Kt/V y volumen de infusión.Resultados:De los 22 pacientes 7 son mujeres, la mediana de edad es de 79,5 años (rango 40-86) y la media de permanencia: 25,13±10,51 meses. Las medias con flujo de diálisis a 600 ml/min y a 500 ml/min fueron respectivamente: Kt:45,5±9,4 y 45,2±9,2 litros, Kt/V:1,52±0,33 y 1,51±0,33 y volumen de infusión: 21,84±4,50 y 21,94±4,51 litros.Conclusión:Según nuestros resultados se puede dializar en hemodiafiltración en línea post-dilucional con flujos de dializado de 500 ml/min sin menoscabo de los parámetros de calidad de hemodiálisis. La disminución del flujo del dializado de 600 a 500 ml/min en hemodiafiltración en línea post-dilucional no produce pérdida en los parámetros de calidad y permite de reducir el consumo de agua. (AU)

Introduction: Online post-dilution hemodiafiltration is a variant of hemodialysis that, according to different studies, can increase patient survival. Initially, and unlike conventional hemodialysis, very high dialysate flows were used (up to 700-800 ml/min), new studies questioned the usefulness of elevation to achieve purifying efficacy.Objective:To analyze the differences produced in Kt, Kt/V and infusion volume in post-dilutional online hemodiafiltration using a dialysate flow at 600 ml/min and 500 ml/min, as well as to evaluate the impact on the consumption of water during the session.Method:22 dialyzed chronic patients undergoing post-dilutional hemodiafiltration on Artis® monitors were included. 440 sessions were studied, 220 with each flow. Age, time of permanence in technique, Kt, Kt/V and infusion volume were studied.Results:Of the 22 patients, 7 were women, with a median age of 79.5 years (range 40-86) and a mean dialysis time of 25.13±10.51 months. The mean values for dialysate flows of 600 ml/min and 500 ml/min were respectively: Kt: 45.5±9.4 and 45.2±9.2 liters, Kt/V: 1.52±0.33 and 1.51±0.33, and infusion volume: 21.84±4.50 and 21.94±4.51 liters.Conclusions:According to our results, on-line post-dilution hemodiafiltration can be dialyzed with dialysate flows of 500 ml/min without impairing the hemodialysis quality parameters. The decrease in dialysate flow from 600 to 500 ml/min in post-dilutional on-line hemodiafiltration does not produce a loss in quality parameters and allows to reduce water consumption. (AU)

Asunto(s)

RESUMEN

PURPOSE: To evaluate the safety and tolerability of subcutaneous IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) administered at high infusion parameters (> 25 mL and > 25 mL/h per injection site) in patients with primary immunodeficiency. METHODS: The Hizentra® Label Optimization (HILO) study was an open-label, parallel-arm, non-randomized study (NCT03033745) of IgPro20 using a forced upward titration design for infusion parameters. Patients experienced with pump-assisted IgPro20 infusions received weekly IgPro20 infusions at a stable dose in the Pump-Assisted Volume Cohort (N = 15; 25-50 mL per injection site) and in the Pump-Assisted Flow Rate Cohort (N = 18; 25-100 mL/h per injection site). Responder rates (percentage of patients who successfully completed ≥ 75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated. RESULTS: Responder rates were 86.7% (13/15, 25 mL) and 73.3% (11/15, 40 and 50 mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50 mL/h), 66.7% (12/18, 75 mL/h), and 61.1% (11/18, 100 mL/h) in the Flow Rate Cohort. Infusion compliance was ≥ 90% in all patients in the Volume Cohort and in 83.3% of patients in the Flow Rate Cohort. The number of injection sites (Volume Cohort) and the infusion duration (Flow Rate Cohort) decreased with increasing infusion parameters. The rate of treatment-emergent adverse events per infusion was low (0.138 [Volume Cohort] and 0.216 [Flow Rate Cohort]). Serum IgG levels remained stable during the study. CONCLUSION: Pump-assisted IgPro20 infusions are feasible at 50 mL and 100 mL/h per injection site in treatment-experienced patients, which may result in fewer injection sites and shorter infusion times. TRIAL REGISTRATION: NCT03033745 ; registered January 27, 2017.

Asunto(s)

RESUMEN

BACKGROUND: Ultrafiltration (UF) in peritoneal dialysis (PD) is mainly driven by the osmotic gradient and peritoneal permeability, but other factors-such as intraperitoneal pressure (IPP)-also have an influence. METHODS: To assess the clinical relevance of these marginal factors, we studied 41 unselected PD patients undergoing two consecutive 2 h, 2.27% glucose exchanges, first with 2.5 L and then with 1.5 L. RESULTS: IPP, higher in the 2.5 L exchange, had a wide interpatient range, was higher in obese and polycystic patients and their increase with infusion volume was higher for women regardless of body size. UF with 2.5 L correlated inversely with IPP and was higher for patients with polycystosis or hernias, while for 1.5 L we found no significant correlations. The effluent had higher glucose and osmolarity in the 2.5 L exchange than in the 1.5 L one, similar for both sexes. In spite of this stronger osmotic gradient, only 21 patients had more UF in the 2.5 L exchange, with differences up to 240 mL. The other 20 patients had more UF in the 1.5 L exchange, with stronger differences (up to 800 mL, and more than 240 mL for 9 patients). The second group, with similar effluent osmolarity and peritoneal equilibration test (PET) parameters than the first, has higher IPP and preponderance of men. The sex influence is so intense that men decreased average UF with 2.5 L with respect to 1.5 L, while women increased it. CONCLUSIONS: With 2.27% glucose, sex and IPP-modulated by obesity, polycystosis, hernias, and intraperitoneal volume-significantly affect UF in clinical settings and might be useful for its management.

Asunto(s)

RESUMEN

The measure of intraperitoneal pressure in peritoneal dialysis is easy and provides clear therapeutic benefits. However it is measured only rarely in adult peritoneal dialysis units. This review aims to disseminate the usefulness of measuring intraperitoneal pressure. This measurement is performed in supine before initiating the drain of a manual exchange with "Y" system, by raising the drain bag and measuring from the mid-axillary line the height of the liquid column that rises from the patient. With typical values of 10-16 cmH2O, intraperitoneal pressure should never exceed 18 cmH2O. With basal values that depend on body mass index, it increases 1-3 cmH2O/L of intraperitoneal volume, and varies with posture and physical activity. Its increase causes discomfort, sleep and breathing disturbances, and has been linked to the occurrence of leaks, hernias, hydrothorax, gastro-esophageal reflux and enteric peritonitis. Less known and valued is its ability to decrease the effectiveness of dialysis significantly counteracting ultrafiltration and decreasing solute clearance to a smaller degree. Because of its easy measurement and potential utility, should be monitored in case of ultrafiltration failure to rule out its eventual contribution in some patients. Although not yet mentioned in the clinical practice guidelines for PD, its clear benefits justify its inclusion among the periodic measurements to consider for prescribing and monitoring peritoneal dialysis.

Asunto(s)

RESUMEN

INTRODUCTION: In post-dilution online hemodiafiltration (OL-HDF), the only recommendation concerning the dialysate, or dialysis fluid, refers to its purity. No study has yet determined whether using a high dialysate flow (Qd) is useful for increasing Kt or ultrafiltration-infusion volume. OBJECTIVE: Study the influence of Qd on Kt and on infusion volume in OL-HDF. MATERIAL AND METHODS: This was a prospective crossover study. There were 37 patients to whom 6 sessions of OL-HDF were administered at 3 different Qds: 500, 600 and 700ml/min. A 5008(®) monitor was used for the dialysis in 21 patients, while an AK-200(®) was used in 17. The dialysers used were: 20 with FX 800(®) and 17 with Polyflux-210(®). The rest of the parameters were kept constant. Monitor data collected were effective blood flow, effective dialysis time, final Kt and infused volume. RESULTS: We found that using a Qd of 600 or 700ml/min increased Kt by 1.7% compared to using a Qd of 500ml/min. Differences in infusion volume were not significant. Increasing Qd from 500ml/min to 600 and 700ml/min increased dialysate consumption by 20% and 40%, respectively. CONCLUSIONS: With the monitors and dialysers currently used in OL-HDF, a Qd higher than 500ml/min is unhelpful for increasing the efficacy of Kt or infusion volume. Consequently, using a high Qd wastes water, a truly important resource both from the ecological and economic points of view.

Asunto(s)