Current partner codePEPTIDESDE
NCT02695862·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

110

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Terlipressin

Timeline

From registration to results.

  1. First posted

    Mar 1, 2016

  2. Study start

    May 5, 2016

  3. Primary completion

    Dec 10, 2017

  4. Study completion

    Jan 31, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Sep 4, 2019

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 24 hours

Secondary outcomes

Death in both groups

Time frame · 42 days

Terlipressin related complications in both groups

Time frame · 72 hours

Rebleed within 42 days

Time frame · 42 days

number of blood transfusion requirement at 5 days

Time frame · 5 days

Incidence of ischaemic hepatitis within 5 days

Time frame · 5 days

Incidence of post bleed acute kidney injury within 5 days

Time frame · 5 days

Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days

Time frame · 5 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

India. Showing up to 24 locations stored in the fast local snapshot.

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

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