Human Albumin for Resuscitation in Surgical Septic Shock: A Randomized Controlled Trial (ALBUS Study)

This study will test whether giving human albumin to keep the blood albumin level above 3.5 g/dL, in addition to standard care, improves survival in patients with surgical septic shock. Septic shock is a life-threatening complication of infection that often requires urgent surgery and intensive care. Current treatment guidelines recommend intravenous fluids and medications to support blood pressure, but the best type of fluid is still uncertain. Human albumin is a natural protein in the blood that helps maintain fluid balance and has anti-inflammatory effects. Previous studies suggest that low albumin levels are linked with worse outcomes in septic patients, and that albumin infusion might improve recovery, but results are mixed and evidence in surgical septic shock patients is lacking. In this randomized controlled trial, adult patients with surgical septic shock admitted to the surgical intensive care unit will be randomly assigned to receive either standard care alone or standard care plus 20% human albumin solution for up to 3 days. The main outcome is survival at 28 days. Secondary outcomes include length of ICU and hospital stay, need for dialysis, ventilator-free days, vasopressor-free days, fluid balance, gastrointestinal recovery, and adverse reactions. The results of this study will help determine whether targeted albumin replacement is beneficial in critically ill surgical patients with septic shock and could guide future fluid resuscitation strategies.

NCT Number	NCT07212582
Lead Sponsor	Mahidol University
Conditions	Critical Illness, Septic Shock
Enrollment	304 participants
Start Date	2025-12-01
Primary Completion	2029-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-19