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

Acute Variceal Bleeding Clinical Trial

Official title: To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding: A Randomized Comparison

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Variceal Bleeding
• Hemorrhage

• NCT number: NCT02695862
• Study type: Interventional
• Source: Institute of Liver and Biliary Sciences, India
• Status: Completed
• Phase: N/A
• Start date: May 5, 2016
• Completion date: January 31, 2018