Not Yet RecruitingPhase 3

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

Thailand304 participantsStarted 2025-12-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (≥18 years) admitted to the surgical intensive care unit (SICU). * Diagnosis or suspicion of surgical infection requiring surgery or surgical intervention within 48 hours of ICU admission. * Septic shock, defined as: * Mean arterial pressure \<65 mmHg after adequate fluid resuscitation or requirement for vasopressors to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour, and * Evidence of organ dysfunction (Sequential Organ Failure Assessment (SOFA) score increase ≥2) or signs of tissue hypoperfusion (serum lactate \>2 mmol/L, oliguria \<0.5 mL/kg/h \>2 h, or clinical evidence of poor peripheral perfusion). Exclusion Criteria: * Refusal of consent or do-not-resuscitate (DNR) status. * More than 24 hours since meeting inclusion criteria. * Contraindication to albumin infusion or history of severe allergic reaction to albumin. * Conditions where albumin infusion is already indicated (e.g., large-volume paracentesis \>5 L, hepatorenal syndrome, spontaneous bacterial peritonitis, plasmapheresis, cirrhosis, nephrotic syndrome, protein-losing enteropathy, severe burns, post-cardiac or thoracic surgery). * Evidence of fluid overload or pulmonary edema (bilateral crepitations, chest infiltrates consistent with pulmonary edema, Central Venous Pressure \>15 mmHg, Pulmonary Artery Occlusion Pressure \[PAOP\] \>18 mmHg, or N-terminal pro-B-type Natriuretic Peptide \[NT-proBNP\] \>900 pg/mL) * End-stage renal disease or receiving chr…

What they're measuring

28-Day All-Cause Mortality

Timeframe: 28 days after randomization

Trial details

NCT IDNCT07212582

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Nuanprae Kitisin, MD

+66896767706 nuanprae.kit@mahidol.ac.th