Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

NCT05240391 | Completed Phase 3 DMC

• 1 other identifier: AIGHEPAT007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Paracentesis-Induced Circulatory Dysfunction

Keywords

Ascites; Paracentesis-Induced Circulatory Dysfunction; Paracentesis

Outcome Measures

Primary Outcomes (1)

• Prevention of Paracentesis induced circulatory disturbance

  Measure the value of plasma renin activity on sixth day after paracentesis

  Day 6

Secondary Outcomes (3)

• Cost effectiveness of Midodrine versus Albumin

  Day 6

• Hepatic Encephalopathy as measured by West-Haven criteria

  Day 6

• Renal outcome post paracentesis

  Day 6

Study Arms (2)

Arm receiving 20% Human Albumin

ACTIVE COMPARATOR

20% Human albumin given intravenously over 4 hours

Drug: Human Albumin 20%

Arm receiving Midodrine

EXPERIMENTAL

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

Drug: Midodrine Hydrochloride

Interventions

Midodrine Hydrochloride DRUG

Midodrine hydrochloride for PICD prevention

Arm receiving Midodrine

Human Albumin 20% DRUG

Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance

Arm receiving 20% Human Albumin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 -

You may not qualify if:

• Patients with acute kidney injury defined as serum creatine of \> 0.3 mg/dl above the baseline
• Severe cardiopulmonary disease
• History of urinary retention
• Pheochromocytoma
• Thyrotoxicosis
• Persistent and excessive supine hypertension define by systolic blood pressure \> 150 mm Hg
• Pregnant patients
• Unable to give informed consent were excluded from the study -

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Location

Related Publications (3)

• Shrestha DB, Budhathoki P, Sedhai YR, Baniya R, Awal S, Yadav J, Awal L, Davis B, Kashiouris MG, Cable CA. Safety and efficacy of human serum albumin treatment in patients with cirrhotic ascites undergoing paracentesis: A systematic review and meta-analysis. Ann Hepatol. 2021 Dec;26:100547. doi: 10.1016/j.aohep.2021.100547. Epub 2021 Oct 6.

  PMID: 34626828 RESULT

• Kulkarni AV, Kumar P, Sharma M, Sowmya TR, Talukdar R, Rao PN, Reddy DN. Pathophysiology and Prevention of Paracentesis-induced Circulatory Dysfunction: A Concise Review. J Clin Transl Hepatol. 2020 Mar 28;8(1):42-48. doi: 10.14218/JCTH.2019.00048. Epub 2020 Mar 26.

  PMID: 32274344 RESULT

• Bai M, Han G. Midodrine for paracentesis-induced circulatory dysfunction. J Clin Gastroenterol. 2014 Mar;48(3):300. doi: 10.1097/MCG.0b013e3182a8bfaf. No abstract available.

  PMID: 24100756 RESULT

MeSH Terms

Conditions

Ascites

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• MITHUN SHARMA, MD FACG AGAF

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Hepatology and Regenerative Medicine

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 15, 2022
• Study Start: February 20, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 5, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)