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

Edward G Clark, Lauralyn McIntyre, Irene Watpool, Jennifer W Y Kong, Tim Ramsay, Elham Sabri, Mark Canney, Gregory L Hundemer, Pierre-Antoine Brown, Manish M Sood, Swapnil Hiremath, Edward G Clark, Lauralyn McIntyre, Irene Watpool, Jennifer W Y Kong, Tim Ramsay, Elham Sabri, Mark Canney, Gregory L Hundemer, Pierre-Antoine Brown, Manish M Sood, Swapnil Hiremath

Abstract

Background: Hemodynamic 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.

Methods: This 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.

Results: Sixty 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).

Conclusions: The 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://ichgcp.net/clinical-trials-registry/NCT03665311?term=NCT03665311&draw=2&rank=1.

Keywords: Acute kidney injury; Albumin; Hypotension; Renal replacement therapy; Ultrafiltration.

Conflict of interest statement

The authors have no competing interests to disclose.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow diagram. ESKD: end-stage kidney disease; SLED: sustained low-efficiency dialysis; AKI: acute kidney injury. See Table 2 for additional details regarding protocol adherence
Fig. 2
Fig. 2
Unadjusted mean blood pressure changes (intra-SLED nadir and post-SLED compared to pre-SLED), and the modeled absolute difference between saline and albumin groups. Error bars show 95% confidence intervals for mean changes in blood pressure. Saline group included 30 patients with 123 SLED sessions; albumin group included 30 patients with 148 SLED sessions. SLED: sustained low-efficiency dialysis; LSM: least square mean; SBP: systolic blood pressure; MAP: mean arterial pressure

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