Overview

To Assess the Efficacy of Midodrine in Prevention of Cirrhosis Related Complications in Children Awaiting Liver Transplantation.

Status:
Not yet recruiting

Trial end date:
2023-06-10

Target enrollment:
0

Participant gender:
All

Summary

Children with cirrhosis awaiting transplantation are more proned 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 [1]. The development of complications in these children may result in death or may preclude them from reaching upto liver transplantation [2]. 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[2-4]. One group will receive only standard medical therapy and other group will receive midodrine and standard medical therapy for 6 months. Mean arterial pressure will be monitored at every OPD visit. At the end of 12 weeks, and 24 weeks, plasma renin activity, incidence of complications related to cirrhosis like new onset ascites, increase in grade of ascites, hyponatremia, acute kidney injury and spontaneous bacterial peritonitis will be assessed. Also the transplant free survival and need for albumin transfusion will be compared between the two groups. In case of liver transplantation or death before 6 months, midodrine will be stopped

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Institute of Liver and Biliary Sciences, India

Treatments:

Midodrine

Criteria

Inclusion Criteria:

Children and Adolescents of age group upto 18 years with cirrhosis and PELD/ MELDNa score
more than 14, on waitlist for liver transplantation following up in the Pediatric
Hepatology Department, ILBS will be prospectively included in this study after informed
consent

Exclusion Criteria:

Presence of Portal vein thrombosis Renal or cardiovascular disease or arterial hypertension
Presence of HCC