跳至主要内容
临床试验/CTRI/2018/08/015182
CTRI/2018/08/015182尚未招募不适用

Randomized trial on Efficacy of Ivabradine, compared with amiodarone, in conversion of Junctional ectopic tachycardia to sinus rhythm in post operative cardiac surgical patients

AIIMS1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2018年6月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
104
试验地点
1
主要终点
Restoration of normal sinus rhythm

研究概览

简要总结

Junctional Ectopic Tachycardia (JET) inpostoperative period is a serious arrhythmia, which often leads to hemodynamicinstability, decreased cardiac output, resulting in serious morbidity andmortality. Hence it is important in achieving rapid control of JET.  None of the drugs have been shown to beconsistently effective in controlling this arrhythmia. Amiodarone has faredwell in this respect, over other drugs, but adverse effects have been commonlyreported with its usage. Recently there are case reports stating thatIvabradine is safe and effective in both congenital and postoperative JET, witha better dosing and adverse effect profile. There has not been any prospectivestudy to demonstrate the same. So we planned this prospective Randomised control trial comparing the efficacy of both these drugs in the management of postoperative JET

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Open Label

入排标准

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

入选标准

  • 1.Pediatric Patients who undergo corrective Open Heart surgery for various congenital heart diseases electively (Age < 18 years) 2.Patients who develop JET until 1 month of surgery
  • Parents/ Guardians of the children giving written informed consent.

排除标准

  • 1 Patients who have Preoperative arrhythmias or who are already on Anti- arrhythmics 2 Preoperative hospital stay > 7 days 3 Severe Liver Dysfunction 4 Multi Organ Dysfunction 5 Parents/ Guardians not giving written consent for inclusion in the trial 6 All emergency surgeries 7 All closed heart surgeries.

结局指标

主要结局

Restoration of normal sinus rhythm

时间窗: Upto 48 hour after institution of therapy

次要结局

  • Secondary outcomes:(1.Controlling of heart rate to age acceptable levels (140 bpm (in upto 3 months),120 bpm in 3months – 2 years and 100 bpm in older children) that allows hemodynamic improvement with/without atrial or AV sequential pacing)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验