Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

• Status: Completed
• Trial end date: 2018-04-30

Summary

• Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences.

• Study Design: Prospective Open Labeled Randomized Controlled Trial.

• Study Period: January 2017 to December 2017

• Intervention- Subjects will be randomized to 3 groups

• All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only

• Monitoring and Assessment: Clinical evaluation will be done at regular intervals.

• Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted.

• Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)

• Phase: N/A

Details

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