Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

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.

More Ascites trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorBaylor College of Medicine
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedMarch 25, 2019
Main results expectedMarch 25, 2027
Study endsJune 25, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT05867602 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.