High Dose Albumin in Refractory Ascites
Phase 2
Recruiting
- Conditions
- Ascites
- Registration Number
- NCT05867602
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Inclusion Criteria:<br><br> 1. Age > 18 years.<br><br> 2. patients diagnosed with liver cirrhosis.<br><br> 3. Refractory ascites which is defined as ascites failing to resolve after maximum<br> tolerable dose of diuretics, and usually require frequent paracentesis.<br><br>Exclusion Criteria:<br><br> 1. Patients < 18y<br><br> 2. patients with no history of liver cirrhosis<br><br> 3. patients with refractory ascites but have transjagular intrahepatic portosystemic<br> shunts (TIPS) with previous 3 months<br><br> 4. Patients with ascites due to other causes, including cardiac, malignant
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of large volume paracentesis needed;The volume of fluid removed in liters per after high-dose albumin administration
- Secondary Outcome Measures
Name Time Method Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension).;Diuretics dosage assessment;Liver related quality of life assessment.;Mortality at 1 year after enrollment;Number and duration of hospital admissions;Treatment cost-effectiveness.