TCTR20231120001RecruitingPhase 2
Half dose human albumin in the prevention of paracentesis-induced circulatory dysfunction in cirrhotic patients with acute decompensation or acute-on-chronic liver failure undergoing paracentesis less than 5 liters: a randomized controlled trial
Faculty of Medicine, Prince of Songkla University0 sites80 target enrollmentStarted: November 20, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Age 18-80
- •2. Chronic hepatitis disease with acute decompensation or acute-on-chronic liver failure
- •3. Grade 3 ascites with abdominal distension or respiratory discomfort
- •4. Ascites release less than 5 liters
Exclusion Criteria
- •1. Disseminated intravascular coagulation
- •2. Hepatocellular carcinoma, BCLC-D before this treatment
- •3. Active pulmonary edema or active congestive heart failure on the date of enrollment
- •4. Serum creatinine > 1.5 mg/dL on the date of enrollment or chronic kidney disease (renal replacement therapy)
- •5. Gastrointestinal bleeding that cannot be stopped
- •6. Hemodynamic instability on the date of enrollment (defined as a mean arterial pressure [MAP] of <65 mmHg or escalating doses of vasopressor/inotropic agents required to maintain a MAP value of >65 mmHg within 24 hours)
- •7. Pregnant
- •8. The patients has a history of allergy to albumin
- •9. The patients does not wish to participate in the research project
- •10. Patients whose life expectancy is through to be less than 2 weeks by the attending physician
Investigators
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