Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

Phase 3

Completed

• Conditions: Paracentesis-Induced Circulatory Dysfunction
• Interventions: Drug: Human Albumin 20%; Drug: Midodrine Hydrochloride

• Registration Number: NCT05240391
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-20
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-15
• Status Verified: 2022-05
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm receiving 20% Human Albumin	Human Albumin 20%	20% Human albumin given intravenously over 4 hours
Arm receiving Midodrine	Midodrine Hydrochloride	Tablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis

Primary Outcome Measures

Name	Time	Method
Prevention of Paracentesis induced circulatory disturbance	Day 6	Measure the value of plasma renin activity on sixth day after paracentesis

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness of Midodrine versus Albumin	Day 6	Cost effectiveness of use of Midodrine compared to Albumin
Hepatic Encephalopathy as measured by West-Haven criteria	Day 6	Hepatic encephalopathy as measured by the West Haven criteria on day 6 in both midodrine and albumin groups
Renal outcome post paracentesis	Day 6	Serum creatinine, serum sodium and serum potassium values on day 6 after paracentesis

Trial Locations

Locations (1)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India