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临床试验/NCT02695862
NCT02695862已完成不适用

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

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年5月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Bolus Terlipressin

Experimental

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

干预措施: Terlipressin (Drug)

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)

干预措施: Terlipressin (Drug)

结局指标

主要结局

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

时间窗: 24 hours

次要结局

  • Death in both groups(42 days)
  • Incidence of post bleed acute kidney injury within 5 days(5 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)
  • Incidence of post EVL(endoscopic band ligation) ulcer bleed within 5 days(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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