Albumin replacement therapy aimed at maintaining serum albumin levels at 3.0 g/dL or higher did not significantly reduce mortality among patients with septic shock in a multicenter randomized clinical trial conducted across intensive care units in Germany.
The trial enrolled 440 adults with septic shock treated in 23 ICUs between October 2019 and May 2022. Participants were randomized to receive either albumin replacement therapy or standard fluid management. Patients in the intervention group received a 60-g loading dose of 20% albumin within 6 to 24 hours after shock onset, followed by additional doses to maintain serum albumin concentrations at 3.0 g/dL or higher for up to 28 days during their ICU stay.
Patients in the control group received standard fluid therapy with crystalloids. Albumin administration was permitted if clinicians considered it necessary, consistent with guideline-based care.
The primary endpoint—90-day all-cause mortality—did not differ significantly between groups. Mortality occurred in 43% of patients in the albumin group compared with 46% of those receiving standard fluid therapy. Kaplan–Meier survival curves likewise showed no meaningful difference in survival during the 90-day follow-up period.
Secondary outcomes were also similar between groups. Mortality at 28 and 60 days was numerically lower among patients receiving albumin but did not reach statistical significance. Measures of organ dysfunction, assessed using Sequential Organ Failure Assessment (SOFA) scores, as well as ICU and hospital length of stay, ventilator-free days, and vasopressor-free days, were comparable between treatment arms.
The study population had a median age of about 70 years, and approximately two-thirds of participants were male. Baseline characteristics were broadly similar across the two groups.
Safety outcomes also showed no meaningful differences. Adverse events occurred in 55% of patients receiving albumin and 48% of controls, with similar types and severity reported in both groups.
Researchers noted that albumin has long been considered a potential adjunct therapy in sepsis because of its role in maintaining oncotic pressure as well as its anti-inflammatory and antioxidant properties. Earlier randomized trials suggested a possible survival benefit among patients with septic shock, providing the rationale for the current study.
The researchers concluded that albumin replacement therapy appeared safe but did not improve 90-day survival in patients with septic shock. Because the trial ended prematurely due to slow enrollment, they emphasized that the findings remain inconclusive and that further studies are needed to determine whether specific patient subgroups may benefit from albumin supplementation.
Disclosures can be found in the study.
Source: JAMA Network Open
