Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Thiamine status and lactate levels
研究概览
简要总结
The objective of this study is to determine whether preoperative parenteral thiamin supplementation does prevent the intra and early postoperative increase of lactate and whether this effect is related to the extent of thiamine deficiency in patients undergoing heart surgery. In addition the prevalence of major thiamin deficiency in patient undergoing heart surgery will be determined.
详细描述
Thiamine (vitamin B1) is a water-soluble vitamin and is involved in several stages of intermediate metabolism which are important for producing energy. Severe thiamin deficiency has been associated with severe lactic acidosis and clinical symptoms of life threatening heart failure.
To date, no study has evaluated thiamine levels in patients undergoing heart surgery and the prevalence of thiamine deficiency is not known. Furthermore it is unknown whether moderately reduced thiamin levels are associated with mild forms of perioperative cardiac failure necessitating prolonged inotropic support.
In this prospective double blind randomised controlled trial of the effect of a parenteral infusion of thiamin before induction of anaesthesia we will investigate the effect on perioperative lactate increase as primary outcome and extent and duration of inotropic support after cardiac surgery. In addition the pharmacokinetics of a intravenous infusion of 300 mg of thiamin on erythrocyte thiamin content and the amount of thiamine excreted in the 24 hours via the urine will be determined.
Baseline thiamin levels in erythrocytes before surgery, as well as nutrition history and body composition will be evaluated as effect modifier.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 100 years
- •planned heart surgery
- •signed informed consent
排除标准
- •pregnancy and lactation
- •known allergic reaction to the drugs used
- •mental condition rendering the patient unable to give informed consent
- •inability or contraindications to perform study procedures
研究组 & 干预措施
Supplementation
6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative
干预措施: Vitamin B1-ratiopharm (Drug)
Placebo
100 ml normal saline, intravenous, preoperative
干预措施: Placebo (Drug)
结局指标
主要结局
Thiamine status and lactate levels
时间窗: perioperative
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); quantity of vitamin B1 in urine and blood concentrations Lactate levels: lactate levels will be determined by blood gas analysis (BGA) within the routine check.
次要结局
- Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay(2-3 weeks)
研究者
Michael J. Hiesmayr
Michael Hiesmayr
Medical University of Vienna