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Safety of Albumin for the Management of Patients With Liver Cirrhosis with kidney injury (Disease).

Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury - A Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/079902
Enrollment
100
Registered
2025-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Personalized Regimen: 1. 25 percent albumin infusion with monitoring of 2. Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature 3. 3Hrly - POCUS, IVC Target less than 20 wit

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with cirrhosis and AKI with sepsis

Exclusion criteria

Exclusion criteria: 1. AKI- secondary to post renal causes such as nephrolithiasis 2. Patient already on maintenance hemodialysis/RRT 3. Patients with shock requiring vasopressors 4. Patient with history of structural heart disease and LVEF less than 50% 5. Patient with known COPD 6. Patient on Mechanical ventilation with P/F ratio less than 200 7. Patient with POCUS based features of volume overload[Presence of B lines ] 8. HCC - Beyond MILAN criteria 9. Patient in need of surgical intervention 10. Patient with history of adverse reaction to Albumin infusion 11. Pregnant or Lactating Women 12. Portal or hepatic vein thrombosis 13. Volume Overload with baseline IVC more than 20 14. Failure to provide informed consent

Design outcomes

Primary

MeasureTime frame
Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse eventsTimepoint: 48hrs or 7days

Secondary

MeasureTime frame
Cumulative dose of albumin (in g/day) used in both arms at 48 hours and day 7Timepoint: 48 hours and day 7;Time to initiation of vasoconstrictors and resolution of AKITimepoint: day 7;Proportion of patients requiring invasive or non-invasive mechanical ventilation at 48 hours and at day7Timepoint: 48 hours and at day7;Proportion of patients developing cardiopulmonary complications in both groupsTimepoint: 7 days;28-day mortality of hospitalized patients with AKI in Cirrhosis.Timepoint: 28 days;Proportion of patients with AKI progression or requiring dialysis at 48 hours and day 7.Timepoint: 48 hours and day 7;SOFA and SIRS score changes at 48 hrs and 7 daysTimepoint: 48 hrs and 7 days

Countries

India

Contacts

Public ContactDr Rakhi Maiwall

Institute of Liver and Biliary Sciences

rakhi_2011@yahoo.co.in01146300000

Outcome results

None listed

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