跳至主要内容
临床试验/CTRI/2010/091/002969
CTRI/2010/091/002969已完成Phase 3 4

Ivabradine in controlling tachycardia among critically ill patients

Fluid Research Grant Christian Medical CollegeVellore Tamilnadu1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月16日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Comparison of the mean heart rate between the treatment and control group 24 hours after the initiation of the treatment.

研究概览

简要总结

This will be a prospective, double blind randomized, cross-over, study to evaluate the ability of Ivabradine to reduce an elevated heart rate in critically ill patients admitted in MICU / MHDU with severe tachycardia. The primary outcome of this study is the proportion of patients with a reduction of heart rate by at least 20 beats per minute (bpm) within 1 day of observation. This trial will randomize 100 patients (men and women, aged above 18 years) admitted in MICU /MHDU with sinus tachycardia (sinus rhythm with HR above 140 bpm). Subjects will be randomized based on computer generated programme to either Ivabradine or placebo group. Subjects in Ivabradine group will receive 2 doses of Ivabradine 7.5 mgs oral/NG at 12 hours apart. Subjects in the placebo group will receive 2 doses of Pantocid 40 mg via NG / oral at 12 hour apart. The period of observation will be 24 hours during which the HR and hemodynamic outcomes will be recorded once in 2 hours. After 12 hours of wash out period the subjects will cross over to second treatment period wherein the participants who received the Ivabradine will be given placebo and those who received placebo will receive Ivabradine. The outcome of interest will again be recorded 2 hourly for 24 hours. In addition any sudden events occurring in rate, rhythm or blood pressure will be noted during the period of the study.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • a)Aged above 18 years b)Sinus rhythm with heart rate above 120 bpm c) 24 hours of admission to the ICU with a diagnosis of shock.
  • d)In case of patients admitted with Organophosphorus poisoning, they should have been off atropine for at least 48 hours.

排除标准

  • ICU Physician assessment Sick sinus syndrome Sinu-atrial block Pacemaker-dependency 3rd degree AV block Ongoing fluid/volume loss On concomitant use of potent CYP3A4 inhibitors: Azole antifungals (ketoconazole, itraconazole), Clarithromycin , erythromycin, josamycin, telithromycin, HIV protease inhibitors (nelfinavir, ritonavir).

结局指标

主要结局

Comparison of the mean heart rate between the treatment and control group 24 hours after the initiation of the treatment.

时间窗: 24 hours

次要结局

  • Hemodynamic parameters up to 24 hrs.(Blood pressure and Mean Arterial Pressure (mm of Hg))

研究者

发起方
Fluid Research Grant Christian Medical CollegeVellore Tamilnadu
申办方类型
Research institution and hospital

研究点 (1)

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