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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

Phase 2
Recruiting
Conditions
paracentesis-induced circulatory dysfunction acute decompensation or acute-on-chronic liver failure
Decompensated cirrhosis, acute-on-chronic liver failure, portal hypertension, acute kidney injury, ascites
Registration Number
TCTR20231120001
Lead Sponsor
Faculty of Medicine, Prince of Songkla University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Compare patient that has PCCD condition and AKI or hyponatremia between patient that recieved albumin and placebo Beginning of the study and day6 Lab automachine
Secondary Outcome Measures
NameTimeMethod
survival in hospital or survival in 28 days between patient that recieved albumin and placebo Day before discharge from hospital and day28 Questionaire
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