Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis
Conditions
Interventions
Intervention1: Midodrine: The intervention arm will be started on midodrine at 0.25mg/kg/day and increased to 0.5mg/kg/day if there is no increase in mean arterial pressure as by 10% after 1 week. Tot
Sponsors
Institute of Liver and Biliary sciences
Eligibility
Inclusion criteria
Inclusion criteria: Children and Adolescents of age group upto 18 years with cirrhosis and PELD/ MELDNa score more than 14, on waitlist for liver transplantation following up in the Pediatric Hepatology Department, ILBS will be prospectively included in this study after informed consent
Exclusion criteria
Exclusion criteria: Presence of Portal vein thrombosis Renal or cardiovascular disease or arterial hypertension Presence of HCC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare incidence of complications (Acute kidney injury, New onset ascites or increase in grade of ascites, Spontaneous bacterial peritonitis, Hyponatremia, Hepatic encephalopathy) of cirrhosis in patients receiving midodrine (at a dose of 0.25 – 0.5mg/kg/day) and standard medical therapy versus standard medical therapy alone for 6 months Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in eGFR from baseline to 6 months Timepoint: 6 months;Change in Mean arterial pressure (MAP) at 1 week and then 2 weekly till the end of the study Timepoint: 6 months;Change in serum sodium from baseline to 6 months Timepoint: 6 months;Frequency of developing AKI by 6 months Timepoint: 6 months;Frequency of development of drug related adverse effects by 6 months Timepoint: 6 months;Frequency of development of Hepatic encephalopathy by 6 months Timepoint: 6 months;Frequency of development of new onset ascites or increase in grade of ascites by 6 months Timepoint: 6 months;Frequency of development of SBP over 6 months Timepoint: 6 months;Plasma renin activity at baseline, at 12 weeks and 24 weeks Timepoint: 12 weeks and 24 weeks;Proportion of patients developing hypertension at 6 months Timepoint: 6 months;Requirement of albumin infusion in 2 groups Timepoint: 6 months;Transplant free survival Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Ashritha A
ILBS
Outcome results
None listed