To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding
Status:
Completed
Trial end date:
2018-01-31
Target enrollment:
Participant gender:
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.