Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study)

Annals of Intensive Care

Mark Canney¹  Pierre-Antoine Brown¹  Swapnil Hiremath¹  Manish M. Sood¹  Gregory L. Hundemer¹  Edward G. Clark²  Jennifer W. Y. Kong³  Tim Ramsay³  Elham Sabri³  Irene Watpool³  Lauralyn McIntyre⁴ 

[1] Division of Nephrology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada;Ottawa Hospital Research Institute, Ottawa, ON, Canada;Division of Nephrology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada;Ottawa Hospital Research Institute, Ottawa, ON, Canada;The Ottawa Hospital–Riverside Campus, 1967 Riverside Drive, K1H 7W9, Ottawa, ON, Canada;Ottawa Hospital Research Institute, Ottawa, ON, Canada;Ottawa Hospital Research Institute, Ottawa, ON, Canada;Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada;

关键词: Renal replacement therapy;    Albumin;    Acute kidney injury;    Hypotension;    Ultrafiltration;   

DOI  :  10.1186/s13613-021-00962-x

来源: Springer

【 摘 要 】

BackgroundHemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treatments in the ICU. Intravenous hyperoncotic albumin may prevent hypotension and facilitate ultrafiltration. In this feasibility trial, we sought to determine if a future trial, powered to evaluate clinically relevant outcomes, is feasible.MethodsThis single-center, blinded, placebo-controlled, randomized feasibility trial included patients with acute kidney injury who started SLED in the ICU. Patients were randomized to receive 25% albumin versus 0.9% saline (control) as 100 mL boluses at the start and midway through SLED, for up to 10 sessions. The recruitment rate and other feasibility outcomes were determined. Secondary exploratory outcomes included ultrafiltration volumes and metrics of hemodynamic instability.ResultsSixty patients (271 SLED sessions) were recruited over 10 months. Age and severity of illness were similar between study groups. Most had septic shock and required vasopressor support at baseline. Protocol adherence occurred for 244 sessions (90%); no patients were lost to follow-up; no study-related adverse events were observed; open label albumin use was 9% and 15% in the albumin and saline arms, respectively. Ultrafiltration volumes were not significantly different. Compared to the saline group, the albumin group experienced less hemodynamic instability across all definitions assessed including a smaller absolute decrease in systolic blood pressure (mean difference 10.0 mmHg, 95% confidence interval 5.2–14.8); however, there were significant baseline differences in the groups with respect to vasopressor use prior to SLED sessions (80% vs 61% for albumin and saline groups, respectively).ConclusionsThe efficacy of using hyperoncotic albumin to prevent hemodynamic instability in critically ill patients receiving SLED remains unclear. A larger trial to evaluate its impact in this setting, including evaluating clinically relevant outcomes, is feasible.Trial registration ClinicalTrials.gov (NCT03665311); First Posted: Sept 11th, 2018. https://clinicaltrials.gov/ct2/show/NCT03665311?term=NCT03665311&draw=2&rank=1

【 授权许可】

CC BY