Status:
RECRUITING
Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
Children with decompensated cirrhosis are more prone to develop various complications. The pathogenesis of cirrhotic complications (ascites, hyponatremia, acute kidney injury) includes release of vaso...
Detailed Description
Aim: To evaluate whether a combination of midodrine and intravenous albumin reduces complications of cirrhosis in decompensated (ascites) cirrhotic children as compared to midodrine alone. Primary ob...
Eligibility Criteria
Inclusion
- Children (≤ 18 years)
- Cirrhosis based on histological/ radiological + endoscopic evidence
- Clinical ascites (≥ grade 2 ascites)
- Informed consent from parents (Assent \> 12 years)
Exclusion
- Arterial hypertension (Mean Arterial Pressure ≥ 95th centile for age)
- Presence of Portal vein thrombosis
- Hepatorenal Syndrome
- Congestive Heart failure
- Respiratory failure(PF ratio \<200)
- Septic shock
- Presence of Hepatocellular Carcinoma
- Transjugular intrahepatic Porto Systemic Shunt
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06091345
Start Date
November 2 2023
End Date
December 31 2025
Last Update
July 1 2025
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110 070