High dose albumin treatment for patients with refractory ascites
Official title: Clinical Efficacy of High-dose Albumin Administration Versus Standard Dose in Patients With Advanced Cirrhosis: Open Label Randomized Clinical Trial
Run by Baylor College of Medicine · NCT05867602 · Data updated 2026-11-12
This study is testing if high-dose albumin infusions can help people with advanced liver cirrhosis and fluid buildup in the abdomen feel better and avoid extra procedures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | March 25, 2019 |
| Main results expected | March 25, 2027 |
| Study ends | June 25, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT05867602 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old diagnosed with liver cirrhosis and refractory ascites.
✕Probably not a fit
Patients under 18 years old or those with ascites due to causes other than liver cirrhosis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of high-dose albumin infusions in patients suffering from refractory ascites due to advanced liver cirrhosis. The study aims to determine whether regular albumin administration can reduce the need for paracentesis and prevent complications associated with fluid accumulation in the abdomen. Patients will be randomly assigned to receive either the albumin treatment or standard care, with various health outcomes measured over a twelve-month period, including mortality rates and quality of life. The trial is designed to provide insights into the effectiveness of albumin in managing this challenging condition.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and survival rates for patients with refractory ascites.
How similar studies have gone: Previous studies have shown promising results with albumin treatment in similar patient populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18 years. 2. patients diagnosed with liver cirrhosis. 3. Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis. Exclusion Criteria: 1. Patients \< 18y 2. patients with no history of liver cirrhosis 3. patients with refractory ascites but have transjagular intrahepatic portosystemic shunts (TIPS) with previous 3 months 4. Patients with ascites due to other causes, including cardiac, malignant
Where it's running
-
Baylor St' Lukes Medical center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Prasun Jalal, MD — Baylor College of Medicine
- Study coordinator: Prasun Jalal, MD
- Email: jalal@bcm.edu
- Phone: 8323551424
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.