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临床试验/NCT03818113
NCT03818113已完成不适用

Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Creatin-Phosphokinase (CK) (U/l)

研究概览

简要总结

Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

排除标准

  • Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

结局指标

主要结局

Creatin-Phosphokinase (CK) (U/l)

时间窗: perioperative during minimal invasive surgery

cardial biomarker for myocardial damage

high specific troponin T (hs-TrT) (μg/l)

时间窗: perioperative during minimal invasive surgery

cardial biomarker for myocardial damage

Creatinkinase Muscle- Brain (CK-MB) (U/l)

时间窗: perioperative during minimal invasive surgery

cardial biomarker for myocardial damage

次要结局

  • mortality rate(from minimal invasive surgery until 30 days post surgery)
  • length of stay in intensive care unit (days)(from minimal invasive surgery until 30 days post surgery)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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