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

• Status: Not yet recruiting
• Trial end date: 2025-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Midodrine

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:

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