Albumin Safe but No Proven Survival Benefit in Septic Shock: JAMA

A new study published in the Journal of the American Medical Association found that patients with septic shock, albumin administration was found to be safe but did not improve 90-day survival. Because the trial was terminated early, the findings are inconclusive, and further studies are recommended to clarify any potential survival benefit.

This research involved 440 patients treated for septic shock across 23 intensive care units in Germany between October 2019 and May 2022. Patients were enrolled within 24 hours of developing septic shock and monitored for outcomes over a 90-day period. The trial was designed to determine whether maintaining higher blood albumin levels could improve survival and other clinical outcomes.

Participants were divided into a group receiving 20% albumin infusions aimed at maintaining serum albumin levels at or above 3.0 g/dL for up to 28 days during their stay in the intensive care unit and the control group receiving standard fluid therapy using crystalloids, which are commonly administered to stabilize blood pressure and maintain circulation in septic patients.

The primary outcome measured was mortality within 90 days. Secondary outcomes included mortality at 28 and 60 days, intensive care and hospital mortality rates, organ dysfunction, total fluid use, duration of hospital stays, and adverse events.

440 patients enrolled with median age of 69 years and nearly two-thirds were male. Here, 222 received albumin therapy and 218 received standard treatment. The results showed that 43.3% of patients in the albumin group died within 90 days when compared to 45.9% in the control group. This difference indicated that albumin supplementation did not meaningfully reduce mortality.

Similarly, no significant differences were observed in secondary outcomes, including shorter hospital stays, reduced organ failure, or improved fluid balance. Importantly, albumin therapy was found to be safe, with no increase in adverse events compared with standard fluid treatment.

The study was terminated earlier than planned because enrollment was slower than expected, reducing the statistical power needed to detect smaller treatment effects. As a result, it remains possible that albumin therapy could offer benefits that were not detectable in this trial. Overall, the study found that while albumin supplementation appears safe, current evidence does not support a clear survival advantage. 

Source:

Sakr, Y., Nierhaus, A., Schumacher, U., Utzolino, S., Jaschinski, U., Petros, S., Fichtner, F., Eimer, C., Putensen, C., Tanev, I., Kreienbühl, L., Kluge, S., Kousoulas, L., Kuhn, S.-O., Jarczak, D., Quintel, M., Bauer, M., & SepNet Critical Care Trials Group and Albumin Replacement Therapy in Septic Shock (ARISS) investigators. (2026). Albumin replacement therapy in septic shock: A randomized clinical trial: A randomized clinical trial. JAMA Network Open, 9(2), e2559297. https://doi.org/10.1001/jamanetworkopen.2025.59297