Role of midodrine with albumin (drug) in Liver Disease with abdominal distention

Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites-An open-label Randomized Controlled trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059106

Enrollment

Registered

2023-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: Midodrine+Albumin+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, incre

Eligibility

Inclusion criteria

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

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 6. Septic shock 7. Presence of Hepatocellular Carcinoma 8. Transjugular intrahepatic Porto Systemic Shunt.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Bikrant Bihari Lal

Institute of Liver and Biliary Sciences

bikrant18may@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026