Status:
NOT_YET_RECRUITING
Human Albumin for Resuscitation in Surgical Septic Shock: A Randomized Controlled Trial (ALBUS Study)
Lead Sponsor:
Mahidol University
Conditions:
Critical Illness
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 i...
Detailed Description
This is a single-center, randomized, open-label, controlled trial designed to evaluate the effect of targeted albumin replacement in adult patients with surgical septic shock. The study will be conduc...
Eligibility Criteria
Inclusion
- 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
- 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 chronic renal replacement therapy.
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT07212582
Start Date
December 1 2025
End Date
December 31 2030
Last Update
November 19 2025
Active Locations (1)
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1
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, Thailand, 10700