Clinical trial NCT02695862: To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding
Official title: To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding: A Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Variceal Bleeding
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%
timeFrame: 24 hours
Secondary outcomes:
measure: Death in both groups
timeFrame: 42 days
measure: Terlipressin related complications in both groups
timeFrame: 72 hours
measure: Rebleed within 42 days
timeFrame: 42 days
measure: number of blood transfusion requirement at 5 days
timeFrame: 5 days
measure: Incidence of ischaemic hepatitis within 5 days
timeFrame: 5 days
measure: Incidence of post bleed acute kidney injury within 5 days
timeFrame: 5 days
measure: Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days
timeFrame: 5 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Shakti P Choudhury, MD
role: PRINCIPAL_INVESTIGATOR
References: