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临床试验/NCT00788242
NCT00788242已完成不适用

The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery

Christoph Ellenberger2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

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
2
主要终点
Postcardiotomy ventricular dysfunction

研究概览

简要总结

The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.

详细描述

Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe aortic stenosis
  • Coronary artery disease associated with poor left ventricular function
  • Parsonnet score >7

排除标准

  • Dementia or inability to understand the study protocol
  • Off-pump and emergent cardiac surgery
  • Poorly controlled diabetes mellitus
  • Severe renal insufficiency
  • Abnormal liver function Child-Plugh - C
  • Body Mass Index < 18 and > 35

研究组 & 干预措施

1

Experimental

Administration of glucose-insulin-potassium

干预措施: Glucose-insulin-potassium (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Postcardiotomy ventricular dysfunction

时间窗: 48h postoperative

次要结局

  • Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)(48 postoperative)
  • Serum troponin and creatinine kinase(Intraoperative - 48 h postoperative)
  • Systolic and diastolic cardiac function using transoesophageal echocardiography(intraoperative)
  • Hypo-/hyperglycemia Hypo-/hyperkaliemia(intraoperative)

研究者

发起方
Christoph Ellenberger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christoph Ellenberger

Médecin Adjoint

University Hospital, Geneva

研究点 (2)

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