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

NCT ID: NCT02695862

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-05
• Study Completion Date: 2018-01-31

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.

Conditions

Acute Variceal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bolus Terlipressin

Injection terlipressin after 2 mg bolus it will be given 2 mg QID

Group Type: EXPERIMENTAL

Terlipressin

Intervention Type: DRUG

Terlipressin continuous(4mg/24hours)

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)

Group Type: ACTIVE_COMPARATOR

Terlipressin

Intervention Type: DRUG

Interventions

Terlipressin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Shakti P Choudhury, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

Arora V, Choudhary SP, Maiwall R, Vijayaraghavan R, Jindal A, Kumar G, Sarin SK. Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding. Hepatol Int. 2023 Feb;17(1):131-138. doi: 10.1007/s12072-022-10416-6. Epub 2022 Dec 21.

Reference Type: DERIVED

PMID: 36542261 (View on PubMed)

Other Identifiers

ILBS-AVB-001

Identifier Type: -

Identifier Source: org_study_id