A Randomized Placebo Controlled Single Center Phase 1 Study to Evaluate Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety as assessed by change in blood glucose levels
研究概览
简要总结
This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.
详细描述
This is a randomized blinded Phase I clinical trial. Thirty patients total will be randomized on a 2:1 basis to treatment (IV Diazoxide added to cardioplegia) vs control (cardioplegia alone). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.
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
- •Age 18 years or older
- •Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
- •Patient scheduled for elective cardiac surgery
排除标准
- •Patient with Diabetes Mellitus on sulfonylurea medications
- •Scheduled for left ventricular assist device (LVAD) or heart transplant
- •Left ventricular ejection fraction < 30%
- •Pre-operative placement or planned use of mechanical circulatory support during surgery
- •Allergy to Thiazide and its derivatives
- •History of gout
- •Patient is pregnant or breastfeeding
研究组 & 干预措施
Diazoxide
IV Diazoxide as additive to hypothermic hyperkalemic cardioplegia.
干预措施: IV Diazoxide (Drug)
Placebo
Placebo as additive to hypothermic hyperkalemic cardioplegia.
干预措施: Placebo (Other)
结局指标
主要结局
Safety as assessed by change in blood glucose levels
时间窗: From first dose of cardioplegia through 48 hours post operatively
Blood glucose levels in mg/dl.
Safety as assessed by mean change in blood pressure
时间窗: From first dose of cardioplegia through 24 hours post operatively
Mean blood pressure measurements in mmHg.
Safety as assessed by incidence of adverse events
时间窗: From first dose of cardioplegia through 7 days post operatively or discharge, whichever comes first
Safety will be assessed by total number of adverse events.
次要结局
- Efficacy as assessed by change in Vasoactive Inotropic Score (VIS)(0, 24, 48 and 72 hours post operatively)
- Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB)(Day of surgery)
- Efficacy as assessed by change in ejection fraction(Day of surgery (pre and post surgery))
- Efficacy as assessed by use of mechanical circulatory support(48 hours post operatively)