High dose albumin treatment for patients with refractory ascites
Clinical Efficacy of High-dose Albumin Administration Versus Standard Dose in Patients With Advanced Cirrhosis: Open Label Randomized Clinical Trial
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05867602 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with liver cirrhosis and refractory ascites.
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.
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 performed: Previous studies have shown promising results with albumin treatment in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.