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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

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

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231120001
Enrollment
80
Registered
2023-11-20
Start date
2022-11-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

1. Patients who were admitted with an acute decompensation/ACLF and have ascites grade 3. 2. 20% human albumin for replacement 4 gm/L of ascites drainage ,1. Patients who were admitted with an acute d
Experimental Drug,No Intervention No treatment
20% Albumin,No medication

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor
Thai Association for the Study of the Liver,The Royal College of Physicians of Thailand,Fundamental Fund, Prince of Songkla University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
survival in hospital or survival in 28 days between patient that recieved albumin and placebo Day before discharge from hospital and day28 Questionaire

Countries

Thailand

Contacts

Public ContactPimsiri Sripongpun

Faculty of Medicine,Prince of songkla University

spimsiri@medicine.psu.ac.th074451479

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026