A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]

Background & Aims: The choice of resuscitation fluid in patients with cirrhosis and sepsis-induced hypotension is unclear. 5% albumin was superior to normal saline in the FRISC study. We 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 endpoint of the study was the attainment of mean arterial pressure (MAP) above 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 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 endpoint (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 (22%) patients in the albumin group due to adverse effects compared to no discontinuations in the plasma-lyte group.Conclusion: In patients with cirrhosis and sepsis-induced hy-potension, 20% albumin leads to a faster improvement in he-modynamics 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.

Automated summary

In patients with cirrhosis and sepsis-induced hypotension, 20% albumin leads to faster improvement in hemodynamics and lactate clearance compared to plasmalyte, while the 28-day survival rate is similar.