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临床试验/NCT02646254
NCT02646254已完成4 期

MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES

SUNDER LAL NEGI0 个研究点目标入组 56 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
56
主要终点
resumption of spontaneous rhythm after aortic cross clamp off

研究概览

简要总结

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

详细描述

Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
1 Year 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Tetralogy of fallot

排除标准

  • TOF with absent pulmonary valve , TOF with pulmonary atresia

结局指标

主要结局

resumption of spontaneous rhythm after aortic cross clamp off

时间窗: 10 minutes

inotropic score

时间窗: First 24 hours

Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours

时间窗: 72hrs

次要结局

  • hospital mortality(30 days)
  • duration of mechanical ventilation in hours(48 hours)
  • ICU stay(7 days)
  • echocardiographic assessment(6 months)

研究者

发起方
SUNDER LAL NEGI
申办方类型
Unknown
责任方
Sponsor Investigator
主要研究者

SUNDER LAL NEGI

Fellow, Cardiac anesthesia.

Post Graduate Institute of Medical Education and Research, Chandigarh

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