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

Acute Variceal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695862
• Other study ID #: ILBS-AVB-001
• Status: Completed
• Phase: N/A
• Start date: May 5, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 31, 2018
• Est. primary completion date: December 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Variceal Bleeding
• Hemorrhage

Intervention

Drug:
• Terlipressin

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%		24 hours
Secondary	Death in both groups		42 days
Secondary	Terlipressin related complications in both groups		72 hours
Secondary	Rebleed within 42 days		42 days
Secondary	number of blood transfusion requirement at 5 days		5 days
Secondary	Incidence of ischaemic hepatitis within 5 days		5 days
Secondary	Incidence of post bleed acute kidney injury within 5 days		5 days
Secondary	Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days		5 days