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NCT Number: NCT05240391

Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

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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Key information

Conditions

Paracentesis-Induced Circulatory Dysfunction Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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 -

Treatment and study plan

Midodrine hydrochloride

Drug

Midodrine hydrochloride for PICD prevention

Human Albumin 20%

Drug

Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance

Primary outcomes

  1. Prevention of Paracentesis induced circulatory disturbance

    Time frame: Day 6

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

Secondary outcomes

  1. Cost effectiveness of Midodrine versus Albumin

    Time frame: Day 6

    Cost effectiveness of use of Midodrine compared to Albumin

  2. Hepatic Encephalopathy as measured by West-Haven criteria

    Time frame: Day 6

    Hepatic encephalopathy as measured by the West Haven criteria on day 6 in both midodrine and albumin groups

  3. Renal outcome post paracentesis

    Time frame: Day 6

    Serum creatinine, serum sodium and serum potassium values on day 6 after paracentesis

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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