"Influence of High Vitamin C Dose on Lactate During Extracorporeal Circulation for Heart Surgery and During the 24 Hours Thereafter." (double Blind Prospective Randomised Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Concentration of lactate
研究概览
简要总结
The aim of our study is to find out whether high doses of vitamin C before cardiopulmonary bypass and during the first 24 hours after that have and impact of lowering the incidence of hyperlactatemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old patients with cardiac disease needing surgery (coronary bypass, valve replacement)
排除标准
- •kidney stones
- •haemochromatosis
- •thalassemias
- •G-6-P deficiency
研究组 & 干预措施
Vitamin C
2g vitamin C (ascorbic acid) iv before cardiopulmonary bypass, 2 g vitamin C iv before removing the aortic clamp, 1g vitamin C iv 8 h after aortic clamp removal and every 8 h thereafter(2 times)
干预措施: ascorbic acid, (Dietary Supplement)
Placebo (saline)
placebo (saline) iv before cardiopulmonary bypass, placebo before removing the aortic clamp, placebo iv 8 h after aortic clamp removal and every 8 h (2 times)
干预措施: Placebo (saline) (Other)
结局指标
主要结局
Concentration of lactate
时间窗: up to 30 hours
Measuring the concentration of lactate before cardiopulmonary bypass, after aortic clamp removal, at ICU admission,then every 6 hours
次要结局
- dose of noradrenaline and other vasopressors(up to 36 hours)
研究者
Andreja Möller Petrun, MD, PhD
MD, PhD, Assistant professor
University Medical Centre Maribor