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

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)

Timeline

Start

2017-05-28

Primary completion

2018-04-30

Completion

2018-04-30

Drugs

Indications