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

Not Applicable

Completed

• Conditions: Acute Variceal Bleeding
• Interventions: Drug: Terlipressin

• Registration Number: NCT02695862
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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 ⩾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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-01
• Study Start: 2016-05-05
• Status Verified: 2017-09
• Primary Completion: 2017-12-10
• Study Completion: 2018-01-31
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

• Pregnant and lactation
• Prior treatment with any vasoactive drugs
• Significant heart or respiratory failure
• Peripheral arteriopathy clinically significant
• Previous heart stroke or significant alteration of the Electrocardiogram
• Hemodynamically unstable
• Refusal to participate in the study
• Hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus Terlipressin	Terlipressin	Injection terlipressin after 2 mg bolus it will be given 2 mg QID
Terlipressin continuous(4mg/24hours)	Terlipressin	Injection terlipressin after 2 mg bolus it will be given 4 mg over 24 hours,and dose will be titrated as per HVPG (Hepatic Venous Pressure Gradient)

Primary Outcome Measures

Name	Time	Method
Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%	24 hours

Secondary Outcome Measures

Name	Time	Method
Death in both groups	42 days
Incidence of post bleed acute kidney injury within 5 days	5 days
Terlipressin related complications in both groups	72 hours
Rebleed within 42 days	42 days
number of blood transfusion requirement at 5 days	5 days
Incidence of ischaemic hepatitis within 5 days	5 days
Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days	5 days

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India