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Comparison between Standard medical therapy plus intravenous albumin vs standard medical therapy alone in patients with variceal upper gastrointestinal bleed.

Standard medical therapy plus intravenous albumin vs standard medical therapy alone in patients with variceal upper gastrointestinal bleed: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046898
Enrollment
136
Registered
2022-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Standard medical therapy Plus albumin: In the SMT plus albumin group, intravenous albumin (100 ml, 20%, given at the rate of 10 ml/hr) would be started after measurement of HVPG of the

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with cirrhosis and variceal bleed presenting within 24 hours of bleed 2. Age 18-65 years 3. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with Child A cirrhosis 2. Patients with normal serum albumin 3. Patients undergoing pre-emptive TIPS 4. Patients with acute on chronic liver failure (diagnosed based on the EASL-CLIF criteria15) at presentation 5. Pregnancy 6. Hypersensitivity to albumin 7. Patients with hepatocellular cancer 8. Patients on anti-platelets or anticoagulants 9. Patients with other co-morbidities such as coronary artery disease, chronic obstructive pulmonary disease, chronic kidney disease and neuromuscular disorders

Design outcomes

Primary

MeasureTime frame
Composite outcome of new-onset SBP, AKI, hepatic encephalopathy and all-cause mortality at 42 days in patients with cirrhosis and variceal bleed in the SMT vs SMT plus albumin groupTimepoint: 42 days—

Secondary

MeasureTime frame
1. 5-day treatment failure rate 2. Need for salvage therapy [additional endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS) or balloon retrograde transvenous occlusion (BRTO)] 3. Duration of hospital/ICU stay 4. Requirement of blood transfusion 5. Change in levels of tumour necrosis factor alpha (TNF- ? ), interleukin-6 (IL-6), and endotoxin levels at day 3 in comparison to day 1 6. Change in HVPG at day 3 in comparison to day 1 Timepoint: 1. 5 days 3. Duration of the hospital stay 4. requirement of blood transfusion 5. day 3 6. day 3—

Countries

India

Contacts

Public ContactDr Shubam Mehta

All India Institute of Medical Sciences

mehta.shubham1493@gmail.com9871037814

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026