Status:
COMPLETED
Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Paracentesis-Induced Circulatory Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in decompensated cirrho...
Eligibility Criteria
Inclusion
- Consecutive patients above 18 years of age who fulfilled Asia Pacific Association of study of liver disease (APASL) criteria for ACLF and required paracentesis for moderate to tense ascites were included in the study.
- Acute on Chronic Liver Failure (ACLF) was defined as an acute hepatic insult manifesting as jaundice (Serum bilirubin ≥ 5 mg/dL (85 micromole/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \< 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis and is associated with a high 28-day mortality -
Exclusion
- Patients with acute kidney injury defined as serum creatine of \> 0.3 mg/dl above the baseline
- Severe cardiopulmonary disease
- History of urinary retention
- Pheochromocytoma
- Thyrotoxicosis
- Persistent and excessive supine hypertension define by systolic blood pressure \> 150 mm Hg
- Pregnant patients
- Unable to give informed consent were excluded from the study -
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05240391
Start Date
February 20 2021
End Date
May 5 2022
Last Update
May 10 2022
Active Locations (1)
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1
Asian Institute of Gastroenterology
Hyderabad, Telangana, India, 500032