Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

Asian Institute of Gastroenterology, India

Status and phase: Completed; Phase 3

Conditions: Paracentesis-Induced Circulatory Dysfunction

Treatments: Drug: Human Albumin 20%; Drug: Midodrine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05240391

AIGHEPAT007

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm receiving 20% Human Albumin

Active Comparator group

Description:

20% Human albumin given intravenously over 4 hours

Treatment:

Drug: Human Albumin 20%

Arm receiving Midodrine

Experimental group

Description:

Tablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis

Treatment:

Drug: Midodrine Hydrochloride