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Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis

NCT05956197 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-07-21

No results posted yet for this study

Summary

Research Objectives- We hypothesized high-dose 25% albumin would be superior to standard medical treatment in improving 3-month mortality in patients with acute decompensation of cirrhosis by improving the systemic hemodynamics and amelioration of systemic inflammation, endothelial function and coagulation.

Aim: To study the efficacy of 25% albumin in reducing 3-month mortality in acute decompensation in cirrhosis.

Primary Objective

• To study the efficacy of 25% albumin in reducing the 3-month mortality.

Secondary Objectives

* To study the cumulative incidence of liver related complications (paracentesis induced circulatory dysfunction (PICD), AKI, hyponatremia, hepatic encephalopathy and variceal bleed)
* Improvement in MELD, CTP, SOFA and AARC scores
* Impact on cardiac function and systemic hemodynamics
* Impact of albumin on development of SBP and non-SBP infections
* Survival free of liver transplant and TIPS at 3 months
* Effect of albumin therapy on immunomodulation, dysfunctional albumin, endothelial function and coagulation at 3 months
* Proportion of patients achieving recompensation at 3 months
* Time to achieve serum albumin \>4 g/dL and its correlation with clinical outcomes.

Conditions

  • Decompensated Cirrhosis

Interventions

OTHER

No intervention

No intervention. This is a cohort study

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956197 on ClinicalTrials.gov