Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients Wit… (NCT05956197) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis
India55 participantsStarted 2023-07-25
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with acute decompensation of cirrhosis
* Patients with age from 18-65 years
Exclusion Criteria:
* Recent Gastrointestinal bleeding within 7 days
* Patients with organic nephropathy (as defined by IAC)
* Patients with Cardiovascular disease or chronic obstructive pulmonary disease
* Systemic arterial hypertension (\>160/90mmhg)
* Presence of hepatocellular carcinoma (outside Milan criteria) ( or portal vein thrombosis
* Budd-Chiari Syndrome
* Pregnancy
* Patients with serum albumin \>3 gm
* Refusal to participate
* Known or suspected hypersensitivity to albumin
* Prior TIPS
* Post liver or kidney transplantation
* Patients enrolled in other clinical trials
* Extrahepatic malignancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall mortality.
Timeframe: 3 months
Trial details
NCT IDNCT05956197
SponsorInstitute of Liver and Biliary Sciences, India