Overview

Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

Status:
Recruiting

Trial end date:
2022-03-20

Target enrollment:
0

Participant gender:
All

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 cirrhosis during large-volume paracentesis. However, it may not be cost-effective and has side effects like volume overload and transfusion reactions. Therefore the investigator proposed to use midodrine which is a drug that increases the mean arterial pressure. The investigators hypothesized that midodrine may be effective in preventing PICD in acute on chronic liver failure patients requiring modest paracentesis. This has already been found to be effective in initial studies in decompensated cirrhosis

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Asian Institute of Gastroenterology, India

Treatments:

Midodrine

Criteria

Inclusion Criteria:

1. 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.

2. 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 Criteria:

1. Patients with acute kidney injury defined as serum creatine of > 0.3 mg/dl above the
baseline

2. Severe cardiopulmonary disease

3. History of urinary retention

4. Pheochromocytoma

5. Thyrotoxicosis

6. Persistent and excessive supine hypertension define by systolic blood pressure > 150
mm Hg

7. Pregnant patients

8. Unable to give informed consent were excluded from the study -