Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Midodrine with standard medical treatment: • 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% (maximum dose
Sponsors
ILBS
Eligibility
Inclusion criteria
Inclusion criteria: Children and adolescents of age group upto 18 years with cirrhosis with stable renal function and · Recurrent ascites – not mobilised by sodium restricted diet (maximum upto 2meq/kg/day) and high dose diuretics 6mg/kg/day spirinolactone and 2mg/kg/day furosemide · Or optimum dose of diuretics cannot be given in view of diuretic induced complications · Or Ascites that recurs within 4 weeks of mobilisation · Or Recurrent ascites – ascites that has recurred 3 times within 12 months despite standard medical treatment
Exclusion criteria
Exclusion criteria: • GIT bleeding in last 1 month • SBP in last 1 month • HE grade 3 or higher • Septic shock • Hepatorenal syndrome • Presence of PVT • Renal or cardiovascular disease or arterial hypertension • Presence of HCC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in eGFR from baseline to 4 weeksTimepoint: 4 weeks;• Change in MAP at 1 week, 4 weeks and 12 weeks from baselineTimepoint: 12 weeks;• Change in serum sodium from baseline to 4 weeks and 12 weeksTimepoint: 12 weeks;• Comparison of proportion of patients with transplant free survival at 12 weeks between the 2 groupsTimepoint: 12 weeks;• Comparison of total number of therapeutic paracentesis (50ml/kg) procedures between the groups by the end of 12 weeks Timepoint: 12 weeks;• Frequency of complete response (elimination of ascites) by 12 weeksTimepoint: 12 weeks;• Frequency of development of adverse effects by 12 weeksTimepoint: 12 weeks;• Frequency of development of HRS by 12 weeksTimepoint: 12 weeks;• Frequency of partial response (persistent ascites not requiring therapeutic paracentesis) by 12 weeksTimepoint: 12 weeks;• Frequency of worsening HE by 12 weeksTimepoint: 12 weeks;• Proportion of patients developing hypertension at 12 weeksTimepoint: 12 weeks;• Time taken to achieve complete responseTimepoint: 12 weeks;• To compare change in plasma renin activity from baseline to 12 weeksTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Seema Alam
ILBS
Outcome results
None listed