A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Diastolic Dysfunction
研究概览
简要总结
Successful heart surgery requires the resumption of a strong beating heart prior to separation from the heart and lung machine. There are different ways to do this. At this hospital, the surgical team usually gives calcium to people when they come off of the heart and lung machine because some doctors believe that calcium can "jump start" the heart. Not every hospital does this.
Some people think that calcium may have a side effect of making the heart more stiff. Stiff hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If calcium makes the heart stiff, then doctors may have to use other medicines to support the heart in the operating room and the intensive care unit. This may ultimately lead to poorer outcomes including a longer stay in the intensive care unit and in the hospital.
This study is being performed to find out if calcium has the side effect of making the heart more stiff. This study compares calcium to placebo. The placebo looks exactly like the calcium, but it contains no calcium. During this study patients may receive placebo instead of calcium. Neither the doctor nor the study team will know which drug the subject will receive.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women greater than 18 years of age
- •Undergoing primary elective valve surgery at Brigham and Women's Hospital
- •Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring
排除标准
- •Patients not consented for TEE as part of routine intra-operative care
- •Any absolute contraindication to TEE
- •Ionized calcium level < 0.80 mmol/L near separation from CPB
- •Myocardial infarction (MI) or acute coronary syndromes < 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium
- •Ejection fraction (EF) < 35%
- •Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler
- •Heart rate (HR) > 100 during 2 data point collections due to E / A wave superimposition
研究组 & 干预措施
Calcium Chloride
Calcium chloride, 10mg/kg
干预措施: Calcium Chloride (Drug)
Placebo
Normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Diastolic Dysfunction
时间窗: 64 enrolled patients or 9 months following start of protocol, whichever comes first
E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.
次要结局
- Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability(64 enrolled patients or 9 months following start of protocol, whichever comes first)
- Need for Inotropic or Vasopressor Support Upon Leaving the OR(64 enrolled patients or 9 months following start of protocol, whichever comes first)
- Length of ICU Stay (Days)(64 enrolled patients or 9 months following start of protocol, whichever comes first)
- Length of Hospital Stay (Days)(64 enrolled patients or 9 months following start of protocol, whichever comes first)
研究者
Michael Nurok, MD, PhD
Cardiac Anesthesiologist
Brigham and Women's Hospital