Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites

NCT06091345 | Completed

• 1 other identifier: ILBS-Cirrhosis-65
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Children with decompensated cirrhosis are more prone to develop various complications. The pathogenesis of cirrhotic complications (ascites, hyponatremia, acute kidney injury) includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis (RAAS) causing sodium and water retention and renal vasoconstriction. The development of complications in these children may result in death or may preclude them from reaching upto liver transplantation. Midodrine is an α1 adrenergic receptor agonist, which increases vascular tone causing rise in the blood pressure, thereby improving renal perfusion and causes RAAS deactivation. The effects of midodrine is documented in reduction of refractory ascites, hepatorenal syndrome and hyponatremia. Albumin is a protien that works by both increasing the colloidal oncotic pressure and improving systemic circulation as well as by effecting the body with anti-inflammatory and antioxidant properties. We have already demonstrated the safety and efficacy of midodrine as well as albumin in cirrhotic children. However, none of these drugs alone provided survival benefit to the patients. Hence, we have planned this study with the ojective to evaluate if combining these 2 drugs (midodrine and albumin) would further reduce the complications and improve the survival in decompensated cirrhotic children.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (9)

• To compare the rate of control of ascites by 6 months in the 2 groups

  6 months

• To compare the change in Mean arterial pressure (MAP) at 1 week, 2 weeks, 4 weeks, 3 months, and 6 months in the 2 groups

  1 week, 2 weeks, 4 weeks, 3 months, and 6 months

• To compare the Plasma renin activity at baseline, 4 weeks, 3mo, 6mo in the 2 groups

  baseline, 4 weeks, 3months, 6months

• Evaluate the change in serum sodium from baseline to 6 months in the 2 groups

  6 months

• To compare the Creatinine from baseline to 6 months in the 2 groups

  6 months

Study Arms (2)

Midodrine+Albumin+SMT

EXPERIMENTAL

* 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, increased to 0.5mg/kg/day after 7 days if MAP does not increase by \>10% . In addition, standard medical therapy will be administered to patients in both the arms.

Drug: Midodrine; Biological: albumin; Other: Standard Medical Treatment

Midodrine+SMT

ACTIVE COMPARATOR

• 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% In addition, standard medical therapy will be administered to patients in both the arms.

Drug: Midodrine; Other: Standard Medical Treatment

Interventions

Midodrine DRUG

• 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%

Midodrine+Albumin+SMT; Midodrine+SMT

albumin BIOLOGICAL

• Albumin infusion 1g/kg/day (max 20g) every two weeks (if pre-infusion serum albumin is \< 3.5 gm/dl

Midodrine+Albumin+SMT

Standard Medical Treatment OTHER

Standard Medical Treatment

Midodrine+Albumin+SMT; Midodrine+SMT

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children (≤ 18 years)
• Cirrhosis based on histological/ radiological + endoscopic evidence
• Clinical ascites (≥ grade 2 ascites)
• Informed consent from parents (Assent \> 12 years)

You may not qualify if:

• Arterial hypertension (Mean Arterial Pressure ≥ 95th centile for age)
• Presence of Portal vein thrombosis
• Hepatorenal Syndrome
• Congestive Heart failure
• Respiratory failure(PF ratio \<200)
• Septic shock
• Presence of Hepatocellular Carcinoma
• Transjugular intrahepatic Porto Systemic Shunt

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110 070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Midodrine; Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: December 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)