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

NCT02695862 | Completed

• 1 other identifier: ILBS-AVB-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%

  24 hours

Secondary Outcomes (7)

• Death in both groups

  42 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

Study Arms (2)

Bolus Terlipressin

EXPERIMENTAL

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

Drug: Terlipressin

Terlipressin continuous(4mg/24hours)

ACTIVE COMPARATOR

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)

Drug: Terlipressin

Interventions

Terlipressin DRUG

Bolus Terlipressin; Terlipressin continuous(4mg/24hours)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 36542261 DERIVED

MeSH Terms

Interventions

Terlipressin

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Dr Shakti P Choudhury, MD

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 1, 2016
• Study Start: May 5, 2016
• Primary Completion: December 10, 2017
• Study Completion: January 31, 2018
• Last Updated: September 4, 2019

Record last verified: 2017-09

Locations

IN (1)