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Randomized Controlled Trial
. 2026 Feb 2;9(2):e2559297.
doi: 10.1001/jamanetworkopen.2025.59297.

Albumin Replacement Therapy in Septic Shock: A Randomized Clinical Trial

Yasser Sakr  1   2 , Axel Nierhaus  3 , Ulrike Schumacher  4 , Stefan Utzolino  5 , Ulrich Jaschinski  6 , Sirak Petros  7 , Falk Fichtner  8 , Christine Eimer  9 , Christian Putensen  10 , Ivan Tanev  11 , Lukas Kreienbühl  12 , Stefan Kluge  3 , Lampros Kousoulas  5 , Sven-Olaf Kuhn  13 , Dominik Jarczak  3 , Michael Quintel  14 , Michael Bauer  1 ; SepNet Critical Care Trials Group and Albumin Replacement Therapy in Septic Shock (ARISS) investigators
Collaborators, Affiliations
Randomized Controlled Trial

Albumin Replacement Therapy in Septic Shock: A Randomized Clinical Trial

Yasser Sakr et al. JAMA Netw Open. .

Abstract

Importance: Albumin supplementation may reduce mortality in patients with septic shock; however, data from randomized clinical trials are limited.

Objective: To assess the impact of albumin administration on outcomes in patients with septic shock.

Design, setting, and participants: This multicenter, open-label randomized clinical trial was conducted between October 21, 2019, and May 2, 2022. Patients from 23 intensive care units in Germany enrolled within 24 hours of the onset of septic shock were followed up for outcome data up to 90 days. The statistical trial report was completed and filed with the federal authorities in December 2023; additional analyses were completed in October 2024. The study was terminated prematurely due to low enrollment rates.

Interventions: Protocol group patients received 20% albumin to maintain serum albumin levels of at least 3.0 g/dL for up to 28 days during their intensive care unit admission. The control group received standard fluid administration with crystalloids.

Main outcomes and measures: The primary end point was 90-day mortality; secondary end points included 28-day, 60-day, intensive care unit and in-hospital mortality, organ dysfunction or failure, total amount of fluid administration and total fluid balance while in the intensive care unit, duration of intensive care and hospital stays, and frequency of adverse events.

Results: Of 440 randomized patients (median [IQR] age, 69 [59-78] years; 290 [65.9%] male), 222 received albumin and 218 received standard fluids. Baseline characteristics were comparable. Ninety-day mortality was 43.3% (91 of 210) in the albumin group vs 45.9% (96 of 209) in controls (relative risk, 0.94; 95% CI, 0.76-1.17; P = .71). No significant differences were observed for secondary end points.

Conclusions and relevance: In this randomized clinical trial of patients with septic shock, albumin administration was safe but did not improve 90-day survival. As this trial was prematurely terminated, results remain inconclusive and additional studies are recommended.

Trial registration: ClinicalTrials.gov Identifier: NCT03869385.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kluge reported receiving grants from Biotest, CytoSorbents, Daiichi Sankyo, and Fresenius Medical Care, and personal fees from ADVITOS, CSL Behring, Fresenius Medical Care, Gilead, MSD, Pfizer, Shionogi, Zoll, AstraZeneca, and Pfizer outside the submitted work. Dr Bauer reported receiving personal fees from CSL Behring. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flowchart of Trial Participation
CONSORT indicates Consolidated Standards of Reporting Trials. aNo informed consent: German regulations allow inclusion based on medical consultant decision provided that informed consent of legal representative or guardian is obtained within 72 hours thereafter, which failed in some cases.
Figure 2.
Figure 2.. Box Plot Showing Daily Serum Albumin Concentration in the Study Groups
SI conversion factor: To convert albumin to grams per liter, multiply by 10.
Figure 3.
Figure 3.. Kaplan-Meier Curves for Survival of Patients Receiving Albumin vs Control Treatment
See this image and copyright information in PMC

References

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