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临床试验/CTRI/2025/09/094562
CTRI/2025/09/094562尚未招募3 期

Effect of short-term targeted heart rate control with Ivabradine versus Esmolol in septic shock with refractory tachycardia: A randomised controlled trial

Department of Anesthesiology Pain Medicine and Critical Care1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月21日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Mean Vasoactive-Inotropic Score

研究概览

简要总结

Sepsis accounts for high mortality in Intensive care unit. Hemodynamic alterations which occur as compensatory mechanism such as Tachycardia increases the mortality in sepsis. Therefore, heart rate control in sepsis improves the myocardial function by increasing diastolic filling time. Beta 1 receptor blockers such as Esmolol have been used in multiple studies to achieve heart rate control and use is associated with reduced vasopressor requirements and cardiac performance.

Another pharamacological agent Ivabradine has been investigated recently in couple of trials which have shown favourable heart rate control, reduced vasopressor requirements, improved macro and microcirculatory parameters in sepsis.

These two agents i.e Esmolol and Ivabradine have never been compared head to head. This study aims to compare the two agents in terms of safety and efficacy hypothesising that Ivabradine is non inferior to Esmolol.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients with septic shock (Vasoactive Inotropic score
  • and sinus tachycardia with a heart rate of more than 110 bpm, after at least 12 hours of ICU admission and stabilization.

排除标准

  • VIS score more than 100 safety concerns with Enteral Ivabradine and negative inotropic effects of Esmolol.

结局指标

主要结局

Mean Vasoactive-Inotropic Score

时间窗: recorded every 6 hours, up to 54 hours

次要结局

  • Mean heart rate(recorded at baseline and every 6 hours, up to 54 hours)
  • Percentage of time-points in which heart rate is within the target range(From 6 to 54 hrs)

研究者

发起方
Department of Anesthesiology Pain Medicine and Critical Care
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr.Loveneesh Dagar

Department of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi

研究点 (1)

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