Liver and Bile
J Hepatol. 2022;77(3):670–82
A randomized controlled trial comparing 20%-albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension (ALPS trial)
Background and aims: The choice of resuscitation fluid in patients with cirrhosis and sepsis-induced hypotension is unclear. Five percent-albumin was superior to normal saline in the FRISC study. The authors compared the efficacy and safety of 20%-albumin, which has greater oncotic properties, to plasmalyte in reversing sepsis-induced hypotension.
Methods: Critically ill patients with cirrhosis underwent open-label randomization to receive either 20%-albumin (0.5–1.0 g/kg over 3 hours, n = 50) or plasmalyte (30 ml/kg over 3 hours, n = 50). The primary end point of the study was the attainment of mean arterial pressure (MAP) > 65 mmHg at 3 hours.
Results: Baseline characteristics were comparable in albumin and plasmalyte groups; arterial lactate (6.16 ± 3.18 mmol/l vs. 6.38 ± 4.77 mmol/l; p = 0.78), MAP (51.4 ± 6.52 mmHg vs. 49.9 ± 4.45 mmHg; p = 0.17) and SOFA (sequential organ failure assessment) score (10.8 ± 2.96 vs. 11.1 ± 4.2; p = 0.68), respectively. Most patients were alcoholics (39%) and had pneumonia (40%). In the intention-to-treat analysis, albumin was superior to plasmalyte in achieving the primary end point (62% vs. 22%; p < 0.001). A faster decline in arterial lactate (p = 0.03), a reduced need for dialysis (48% vs. 62%; p = 0.16), and a longer time to initiation of dialysis (in hours) (68.13 ± 47.79 vs. 99.7 ± 63.4; p = 0.06) were seen with albumin. However, the 28-day mortality rate was not different (58% vs. 62%; p = 0.57) and treatment had to be discontinued in 11 patients (22%) in the albumin group due to adverse effects compared to no discontinuations in the plasmalyte group.
Conclusion: In patients with cirrhosis and sepsis-induced hypotension, 20%-albumin leads to a faster improvement in hemodynamics and lactate clearance than plasmalyte, while 28-day survival was similar. However, patients on 20%-albumin need to be closely monitored as it was more often associated with pulmonary complications.