News: Albumin therapy shows no septic shock survival benefit, study finds

In a recent clinical trial, albumin replacement therapy did not reduce 90-day mortality in patients with septic shock, compared with standard crystalloid therapy, according to a clinical trial published in JAMA Network Open. Albumin was found to be safe, but the trial ended early with inconclusive results.

The study was conducted as a multicenter randomized trial of 440 patients with septic shock. It was a prospective, open-label trial across 23 intensive care units (ICU) in Germany, within 24 hours of septic shock onset between 2019 and 2022. Patients were randomly assigned to receive either a 60-g loading dose of 20% human albumin, followed by dosing to maintain serum albumin levels of ≥ 3.0 g/dL for up to 28 days during ICU admission, or standard fluid administration with crystalloids.

All patients received standard ICU care and were followed for 90 days. The primary outcome was the 90-day all-cause mortality rate. Secondary outcomes were 28-day and 60-day mortality rates, organ dysfunction, length of stay, ventilator-free and vasopressor-free days, fluid administration volumes, and adverse events.

The study ended prematurely due to low enrollment rates during the COVID-19 pandemic. The primary outcome was available for analysis in 210 patients in the albumin group and 209 patients in the control group.

Adverse events occurred in 54.5% of patients in the albumin group and 48.1% of patients in the control group, with similar frequencies and severities of both sepsis-related and non-sepsis-related events between the groups.

“In this randomized clinical trial study of patients with septic shock, albumin administration aiming to maintain serum albumin concentrations greater than 3.0 g/dL was safe but did not improve 90-day survival in these patients,” the authors wrote. “Uncertainty remains due to premature termination of the study, and additional studies are recommended.”

Editor’s note: To read the full report, click here. To read additional coverage of this study from MedScape, click here.