Role of midodrine with albumin (drug) in Liver Disease with abdominal distentio
Phase 3
- Conditions
- Health Condition 1: K769- Liver disease, unspecified
- Registration Number
- CTRI/2023/10/059106
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children (= 18 years)
2.Cirrhosis based on histological/ radiological + endoscopic evidence
3.Clinical ascites (= grade 2 ascites)
4.Informed consent from parents (Assent > 12 years)
Exclusion Criteria
1.Arterial hypertension (Mean Arterial Pressure = 95th centile for age)
2.Presence of Portal vein thrombosis
3.Hepatorenal Syndrome
4.Congestive Heart failure
5.Respiratory failure(PF ratio <200)
6.Septic shock
7.Presence of Hepatocellular Carcinoma
8.Transjugular intrahepatic Porto Systemic Shunt.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare difference in composite incidence of complications of cirrhosis (Acute kidney injury, ascites, hyponatremia, hepatic encephalopathy) in patients receiving midodrine and albumin versus those receiving midodrine alone.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method Evaluate the change in serum sodium from baseline to 6 months in the 2 groupsTimepoint: 6 months;To compare the change in Mean arterial pressure in the 2 groupsTimepoint: 1 week, 2 weeks, 4 weeks, 3 months, and 6 months;To compare the Creatinine from baseline to 6 months in the 2 groupsTimepoint: 6 months;To compare the Cytokines levels in the 2 groupsTimepoint: baseline and 6 months;To compare the Frequency of development of drug related adverse effects by 6 monthsTimepoint: 6 months;To compare the Plasma renin activity in both groups.Timepoint: baseline, 4 weeks, 3mo, 6mo in the 2 groups;To compare the presence of Minimal Hepatic encephalopathy in the 2 groupsTimepoint: 6 months;To compare the rate of control of ascites by 6 months in the 2 groupsTimepoint: 6 months;To compare the Transplant free survival in the 2 groupsTimepoint: 6 months