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Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

NCT05240391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-10

No results posted yet for this study

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

Conditions

  • Paracentesis-Induced Circulatory Dysfunction

Interventions

DRUG

Midodrine Hydrochloride

Midodrine hydrochloride for PICD prevention

DRUG

Human Albumin 20%

Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • MITHUN SHARMA, MD FACG AGAF · Asian Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-20
Primary Completion
2022-05-01
Completion
2022-05-05

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240391 on ClinicalTrials.gov