Terlipressin (drug) in Acute Variceal Bleeding (Liver Disease).

Completed

Conditions: Other and unspecified cirrhosis ofliver,

Registration Number: CTRI/2018/02/011992

Lead Sponsor: Institute of liver and Biliary Sciences

Brief 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 â©¾8 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 1mg 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Any patient with only acute esophageal variceal bleeding (as defined by Asian pacific Association for the study of Liver Disease) 2) Informed consent to participate in the study 3) Age 18 to 70 years.

Exclusion Criteria

Pregnant and lactation 2) Prior treatment with any vasoactive drugs 3) Significant heart or respiratory failure 4) Peripheral arteriopathy clinically significant 5) Previous heart stroke or significant alteration of the Electrocardiogram 6) Hemodynamically unstable 7) Refusal to participate in the study 8) Hypertension.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re bleeding in both group	2 Years

Secondary Outcome Measures

Name	Time	Method
Death in both groups	2 Years
Terlipressin related complications in both groups	2 Years

Trial Locations

Locations (1): Institute of Liver and Biliary Science
🇮🇳
Delhi, DELHI, India
Institute of Liver and Biliary Science
🇮🇳Delhi, DELHI, India
Dr Shakti P Choudhury
Principal investigator
01146300000
shakti784@gmail.com