Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites
Liver Cirrhosis
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria: Children (≤ 18 years) Cirrhosis based on histological/ radiological + endoscopic evidence Clinical ascites (≥ grade 2 ascites) Informed consent from parents (Assent > 12 years) Exclusion Criteria: 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
Sites / Locations
- Institute of Liver & Biliary Sciences (ILBS)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Midodrine+Albumin+SMT
Midodrine+SMT
Albumin infusion 1g/kg/day (max 20g) every two weeks (if pre-infusion serum albumin is < 3.5 gm/dl Plus Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% . In addition, standard medical therapy will be administered to patients in both the arms.
• Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% In addition, standard medical therapy will be administered to patients in both the arms.