Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-20

Study Completion Date

2022-05-05

Brief Summary

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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

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Detailed Description

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Conditions

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Paracentesis-Induced Circulatory Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm receiving 20% Human Albumin

20% Human albumin given intravenously over 4 hours

Group Type ACTIVE_COMPARATOR

Human Albumin 20%

Intervention Type DRUG

Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance

Arm receiving Midodrine

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

Group Type EXPERIMENTAL

Midodrine Hydrochloride

Intervention Type DRUG

Midodrine hydrochloride for PICD prevention

Interventions

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Midodrine Hydrochloride

Midodrine hydrochloride for PICD prevention

Intervention Type DRUG

Human Albumin 20%

Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance

Intervention Type DRUG

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No