Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Paracentesis-Induced Circulatory Dysfunction

Intervention / Treatment
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* Drug: Midodrine Hydrochloride
* Drug: Human Albumin 20%


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm receiving 20% Human Albumin<br>20% Human albumin given intravenously over 4 hours | Drug: Human Albumin 20%<br>* Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance<br>|
| Experimental: Arm receiving Midodrine<br>Tablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis | Drug: Midodrine Hydrochloride<br>* Midodrine hydrochloride for PICD prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Paracentesis induced circulatory disturbance | Measure the value of plasma renin activity on sixth day after paracentesis | Day 6 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ascites, Paracentesis-Induced Circulatory Dysfunction, Paracentesis