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临床试验/NCT01681095
NCT01681095已完成2 期

Custodiol-HTK Solution as a Cardioplegic Agent- A Prospective Non-Inferiority Randomized Clinical Trial

Marc Sakwa, MD1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)

研究概览

简要总结

The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.

详细描述

The objective of this study is to demonstrate that Custodiol is not inferior to cold cardioplegic solution for myocardial protection by comparing standard cold blood cardioplegia to Custodiol solution with respect to myocardial injury as measured by Creatine phosphokinase MB isoenzyme (CK-MB),troponin-I at 7 hours post surgery and changes in ejection fraction by trans-thoracic echocardiogram (TTE)or trans-esophageal echocardiogram (TEE) at 24 hours post surgery.

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
None

入排标准

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

入选标准

  • Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes
  • Patients age 18 and older

排除标准

  • Pregnant women*
  • Urgent or emergent cases
  • Repeat cardiovascular surgical procedures
  • Patients on dialysis
  • Any known allergies to components of either cardioplegia solution *All women of child bearing potential must have a negative serum or urine pregnancy test.

研究组 & 干预措施

Cardioplegia: Custodiol HTK Solution

Experimental

Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.

Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C.

干预措施: Custodiol HTK (Drug)

Cold Blood Cardioplegia

Active Comparator

Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.

After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.

干预措施: Cold Blood Cardioplegia (Drug)

结局指标

主要结局

Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)

时间窗: Baseline and 24 hours post surgery

LV ejection fraction by TTE, difference from baseline at 24 hours post surgery

Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)

时间窗: Baseline and 7 hours post surgery

Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery

Change in Troponin I

时间窗: Baseline and 7 hours post surgery

Troponin I values, difference from baseline 7 hours post surgery

次要结局

  • Cardiac Dysrhythmias(up to 36 hrs post surgery)
  • Duration of Vasopressor / Inotropic Agent(up to 36 hours post procedure)
  • Time on Mechanically Assisted Ventilation(up to 36 hours post procedure)
  • Intensive Care Unit (ICU) Length of Stay(up to 100 days after admission)
  • Cardiac Marker - Troponin-I(48 hours post procedure)
  • Cardiovascular Mortality(30 days post procedure)
  • Myocardial Infarction(up to 36 hours post procedure)
  • Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)(48 hours post procedure)
  • All Cause Mortality(30 days post procedure)
  • Postoperative Inotropic Infusion >20 Minutes(during operative procedure)

研究者

发起方
Marc Sakwa, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marc Sakwa, MD

Principal Investigator

William Beaumont Hospitals

研究点 (1)

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