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OpenTrials
Completed

NCT Number: NCT02695862

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  1. Death in both groups

    Time frame: 42 days

  2. Terlipressin related complications in both groups

    Time frame: 72 hours

  3. Rebleed within 42 days

    Time frame: 42 days

  4. number of blood transfusion requirement at 5 days

    Time frame: 5 days

  5. Incidence of ischaemic hepatitis within 5 days

    Time frame: 5 days

  6. Incidence of post bleed acute kidney injury within 5 days

    Time frame: 5 days

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

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding: A Randomized Comparison

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2016
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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