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

NCT07212582 | Not Yet Recruiting Phase 3

• 1 other identifier: ALBUS_SIRIRAJ
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Critical Illness; Septic Shock

Keywords

human albumin; fluid resuscitation; colloids; Surgical Intensive Care Unit (SICU); surgical septic shock; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 28-Day All-Cause Mortality

  Mortality from any cause within 28 days of ICU admission, assessed by review of hospital records and/or telephone follow-up if the patient is discharged before Day 28.

  28 days after randomization

Secondary Outcomes (6)

• ICU Length of Stay

  From ICU admission until ICU discharge or death in the ICU, assessed for up to 90 days.

• Hospital Length of Stay

  From hospital admission until hospital discharge or in-hospital death, assessed for up to 90 days.

• Vasopressor-Free Days

  28 days after randomization

• 7-Day Cumulative Fluid Balance

  First 7 days after randomization

• Acute Kidney Injury Requiring Renal Replacement Therapy

  Up to 28 days after randomization

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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.

Other: Standard Care (in control arm)

Standard Care Plus Albumin

EXPERIMENTAL

Patients in this group will receive standard sepsis management as above, plus intravenous 20% human albumin solution. On admission, 50 mL of 20% albumin will be infused over 2 hours, followed by additional doses for up to 72 hours, titrated according to daily serum albumin levels. The target is to maintain serum albumin \>3.5 g/dL: 1 vial every 12 hours if 2.5-3.4 g/dL, or every 6 hours if \<2.5 g/dL. Infusion will be withheld in the presence of fluid overload, pulmonary edema, or severe hypernatremia.

Drug: Human Albumin 20% Solution; Other: Standard Care (in control arm)

Interventions

Human Albumin 20% Solution DRUG

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.

Standard Care Plus Albumin

Standard Care (in control arm) OTHER

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.

Standard Care; Standard Care Plus Albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Refusal of consent or do-not-resuscitate (DNR) status.
• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkoknoi, 10700, Thailand

Location

MeSH Terms

Conditions

Critical Illness; Shock, Septic

Interventions

Serum Albumin, Human; Solutions; Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Nuanprae Kitisin, MD

CONTACT

+66896767706; nuanprae.kit@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Patients, treating clinicians, and investigators are aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized in a 1:1 ratio to receive either standard care alone or standard care plus intravenous 20% human albumin solution for up to 72 hours. Randomization will be performed using block randomization with a block size of 4.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)