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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2030

Conditions
Critical IllnessSeptic Shock
Interventions
DRUG

Human Albumin 20% Solution

Intravenous 20% human albumin solution (50 mL per vial). In the experimental arm, patients receive 50 mL over 2 hours on admission, followed by additional doses for up to 72 hours, titrated to maintain serum albumin \>3.5 g/dL. If albumin is 2.5-3.4 g/dL, 1 vial every 12 hours is given; if \<2.5 g/dL, 1 vial every 6 hours is given. Infusion is withheld if there is fluid overload, pulmonary edema, or severe hypernatremia.

OTHER

Standard Care (in control arm)

Patients in this group will receive standard sepsis management according to international guidelines. This includes source control, intravenous broad-spectrum antibiotics, balanced crystalloids, vasopressors, and adjunctive therapies (e.g., corticosteroids, thiamine, ventilatory and renal support) as clinically indicated. Albumin may be given if separate indications arise (e.g., perioperative use, severe hypoalbuminemia \<2.5 g/dL with capillary leakage), at the discretion of the treating physician.

Trial Locations (1)

10700

Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok

All Listed Sponsors
lead

Mahidol University

OTHER