Efficacy and safety of midodrine in refractory or recurrent ascites in children with cirrhosis

Not Applicable

Suspended

• Conditions: Health Condition 1: K740- Hepatic fibrosis

• Registration Number: CTRI/2021/12/038602
• Lead Sponsor: ILBS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups <br/ ><br> <br/ ><br>Timepoint: 12 weeks <br/ ><br>