Abstract
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
Highlights
Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treat‐ ments in the intensive care unit (ICU)
Hemodynamic instability is a frequent complication of all forms of renal replacement therapy (RRT) commonly used in the intensive care unit (ICU), including sustained low-efficiency dialysis (SLED) [1]
A total of 271 SLED sessions were performed in this cohort, 123 in the saline group and 148 in the albumin group
Summary
Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treat‐ ments 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. Hemodynamic instability is a frequent complication of all forms of renal replacement therapy (RRT) commonly used in the intensive care unit (ICU), including sustained low-efficiency dialysis (SLED) [1]. Intravenous hyperoncotic albumin may be administered prior to, or during RRT, in order to prevent HIRRT and/or augment ultrafiltration [10]. It works by promoting intravascular plasma refilling from the extravascular compartment to compensate for fluid removal with ultrafiltration. Intravenous albumin is expensive [14] and not without potential harms [10]
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