NCT05240391

Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

Midodrine Versus Albumin During Large-volume Paracentesis and Its Effect on Paracentesis Induced Circulatory Disturbance in Patients With Acute on Chronic Liver Failure - A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Midodrine Hydrochloride	Midodrine hydrochloride for PICD prevention
DRUG	Human Albumin 20%	Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance

Timeline

• Start date: 2021-02-20
• Primary completion: 2022-05-01
• Completion: 2022-05-05
• First posted: 2022-02-15
• Last updated: 2022-05-10

Locations

1 site across 1 country: India