Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery.
This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the outcome and complications after cardiac surgery.
详细描述
Patients undergoing cardiac surgery are at significant risk for multiple major complications beyond those associated with other major operations. Most patients survive these events, but up to 10% develop injury to organ systems including the kidneys, lungs, pancreas, brain, etc. It has been shown that the stress that occurs during this critical period (cardiac surgery) leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which seem to contribute to these complications.
This study will investigate the effects of high doses of intravenous (IV) Vitamin C administered before, during and after the cardiac surgery.
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
- •Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.
排除标准
- •History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.
研究组 & 干预措施
A-Ascorbic Acid (Vitamin C)
Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.
干预措施: Ascorbic Acid (Drug)
B-5% Dextrose Water or Normal Saline
5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.
干预措施: 5 % Dextrose Water or Normal Saline (Other)
结局指标
主要结局
Mortality
时间窗: 30 days
Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)
次要结局
- Renal Insufficiency(hospital discharge)