Role of Preoperative IV Administration of Vitamin C in Patients at Risk for Cardiac Vasoplegia After Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- amount of noradrenaline need
研究概览
简要总结
This is a parallel group double-blind, randomized-controlled trial with 1:1 randomization ratio which will be conducted over a period of 6 months to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB. Two groups will be included; Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid (treatment group) and Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (control group). Each patient will be subjected to assessments of the doses of noradrenaline given from the end of surgery until weaning as well as hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery.
详细描述
Background and Rationale:
Cardiac vasoplegia is a known phenomenon after cardiopulmonary bypass (CPB) occurring in up to 44% of patients. Severe forms of such condition refractory to vasopressors are associated with poor outcomes. New agents e.g. ascorbic acid that can alter the systemic vascular resistance in cardiac vasoplegia have been suggested as an attempt to avoid or at least reduce the use of IV vasopressors and their induced systemic hypo-perfusion.
Objectives :
- Primary objective: to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
- Secondary objectives: to study the effect of vitamin C administration on the time to weaning from noradrenaline
Study population & Sample size :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.
排除标准
- •Patients who undergo surgeries without cardiopulmonary bypass (off-pump)
- •Patients undergoing surgeries for congenital cardiac disease
- •Patients performing heart transplantation and combined cardiac surgeries
- •Patients with low pre-operative left ventricular ejection fraction (LVEF)
- •Patients refusing to participate
- •Patients who receive vasopressors other than noradrenaline
研究组 & 干预措施
Group (A)
consists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid
干预措施: IV of vitamin C (Drug)
结局指标
主要结局
amount of noradrenaline need
时间窗: 3 days
to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
次要结局
- duration of noradrenaline need(3 days)
研究者
Hesham Mostafa Ahmed Alkady
Prof. A. Dr.
Cairo University