Prophylactic Use of Hydroxycobolamin in the Prevention of Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in systemic vascular resistance
研究概览
简要总结
Several studies have described the use of alternative drugs as methylene blue (MB) (3) other than the standard limited options of the use of vasopressors and systemic corticosteroids (4) especially in the face of increasing incidence of vasoplegic syndrome. Hydroxycobolamin (HCO) has been used for treating cyanide poisoning for more than 40 years. Persistant and significant hypertension occurred as a result of the ability of (HCO) to bind nitric oxide (NO) to form nitrocobalamin.
In this prospective randomized controlled trial, we hypothesized that the prophylactic use of HCO in high risk patients after CPB may decrease the incidence of vasoplegia.
详细描述
Patients and methods
This randomized placebo-controlled single -center study will be conducted in Ain Shams University Hospital from May 2019 till October 2022. Patients undergoing Cardiopulmonary bypass grafting (CABG) and/or valve surgery will be approached by their anesthesia providers. Those who will be accepted to participate in the study were screened for inclusion and exclusion criteria on the day of the surgery or one day before. Informed consent will be taken from all participants by anesthesia providers. The duration of the study will be from the start of cardiac surgical procedure till after separation from CPB by 60 minutes.
Patients will be included in the study are aged from18- 60 yrs old undergoing CABG and/or valve surgery on CPB and have 2 or more preoperative risk factors for Vasoplegia including
- Using preoperative beta blocker (BB) or Angiotensin converting enzyme inhibitor (ACEI).
- preoperative EF < 35%
- History of thyroid disease
- Preoperative diuretics
Exclusion criteria are:
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the study are aged from18- 60 yrs old undergoing CABG and/or valve surgery on CPB and have 2 or more preoperative risk factors for Vasoplegia,
- •Using preoperative beta blocker (BB) or Angiotensin converting enzyme inhibitor (ACEI).
- •preoperative EF < 35%
- •History of thyroid disease
- •Preoperative diuretics
排除标准
- •Exclusion criteria are:
- •Emergency surgery
- •Severe renal Insufficiency (preoperative Cr > 1.8 mg / dL)
- •Severe hepatic disease (preoperative diagnosis of liver cirrhosis or recent elevated liver function tests
- •Pregnant or woman of child bearing potential
- •Know hypersensitivity to hydroxycobolamin
研究组 & 干预措施
Group (OH CO)
Group (OH CO): 30 patients will receive hydroxycobolamin (Cyanokit) 5 gm intravenously(iv) through the central venous catheter as bolus over 15 min reconstituted in 200 ml of NS.
干预措施: Hydroxycobalamin (Drug)
Group (C) control
Group (C) control: 30 patients will receive 200ml of NS over 15 min iv.
干预措施: Hydroxycobalamin (Drug)
结局指标
主要结局
change in systemic vascular resistance
时间窗: within 30 and 60 minutes
Primary outcome will be change in MAP between baseline and all time points (30 \& 60 min after CPB initiation) and (30 \& 60 min after CPB separation) between the two groups and within the same group.
次要结局
未报告次要终点
研究者
Dina Salah Eldin Mahmoud Badre
Associate Professor of Anesthesia
Ain Shams University