drugset / Trial / NCT04816240

Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.

NCT04816240

RandomizedParallel-groupDouble-blindTreatment

Summary

The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis. Cirrhosis is a leading cause of disability and mortality worldwide. Cirrhosis occurs in 50% of patients over 10 years. Decompensated cirrhosis carries a poor prognosis because the median survival time is about 2 years and it imposes a heavy burden on health care costs mainly due to the need for repeated hospital admission. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). A lot of times the prognosis is poor and the main factors leading to it are - AKI/HRS-NAKI, Hyponatremia, Grade of ascites-Refractory ascites, Sarcopenia, low Mean arterial pressure. Post review of the literature, it is realized that there are some gap areas - * It is unknown whether combination of vasoconstrictor with albumin further decreases the need for paracentesis in patients of refractory ascites. * There are no studies till date on using combination of vasoconstrictor with albumin for refractory ascites. * There are no studies evaluating the prevalence and incidence of HRS-NAKI using the new definitions in patients with refractory ascites and impact of combining vasoconstrictor and albumin in improving renal outcomes in these patients.

Timeline

Start
2021-05-15
Primary completion
2022-03-19
Completion
2022-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Midodrine Small molecule 15 mg
Background Albumin Protein / enzyme biologic 40 g

Indications