NCT04621617

Midodrine and Albumin in Patients With Refractory Ascites

Midodrine and Albumin in Patients With Refractory Ascites. A Randomised Controlled Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Refractory ascites is seen in 5-10% of patients with cirrhosis.Decompensated cirrhosis with refractory ascites has a mortality rate of around 40% in a year and a median survival of 6 months.Portal hypertension and splanchnic vasodilation are major factors in the development of ascites.The treatment of refractory ascites involves salt restriction, diuretics, large volume paracentesis (LVP), transjugular Intrahepatic Portosystemic shunt (TIPS) and Liver Transplantation (LT). Currently the only curative treatment is LT. However, LT is limited due to organ shortage and high cost. Long-term human albumin (HA) administration in patients with uncomplicated and refractory ascites, has shown to improve survival or delay the complications of cirrhosis. Midodrine, an oral α1- adrenergic agonist has been used in refractory ascites with variable results. However, there is no study on the use of long term Midodrine and HA in patients with refractory ascites. Therefore, we plan to study the effect of long term midodrine and HA in patients with refractory ascites.

Conditions

• Refractory Ascites

Interventions

Type	Name	Description
DRUG	Albumin	Human albumin will be administered by intravenous infusion at a dose of 1.5 gm/kg/week for 2 weeks followed by HA 40 grams every 7days
DRUG	Midodrine	Oral Midodrine will be given at a dose of 7.5 mg three times in a day
DRUG	Standard medical therapy (SMT)	SMT will include nutritional support, rifaximin, lactulose or lactitol, diuretics, SBP prophylaxis with norfloxacin, restriction of sodium, multivitamins, and other supportive measures as deemed necessary. LVP will be done as needed. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-12-01
• Completion: 2022-04-01
• First posted: 2020-11-09
• Last updated: 2020-11-09