NCT02695862

To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding

Completed NA Last updated 4 September 2019

What this trial tests

NA trial testing Terlipressin in Acute Variceal Bleeding in 110 participants. Completed in 31 January 2018.

Timeline

5 May 2016

Primary endpoint
10 December 2017

31 January 2018

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	5 May 2016
Primary completion	10 December 2017
Estimated completion	31 January 2018
Sites	1 location across India

Drugs / interventions tested

• Terlipressin — full drug profile →

Conditions studied

• Acute Variceal Bleeding — all drugs for Acute Variceal Bleeding →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 70, any sex, with Acute Variceal Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is single centered; prospective, parallel arm randomized controlled trial.The patients will be who presented to Institute of Liver \& Biliary Sciences with esophageal variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every 6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl. Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg) followed by Endoscopic variceal ligation. All patients will received prophylactic antibiotics; antibiotics will be stopped if there will no other indication to continue. After confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient) measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding.
   Arora V, Choudhary SP, Maiwall R, Vijayaraghavan R, et al · · 2023 · cited 17× · PMID 36542261 · DOI 10.1007/s12072-022-10416-6