Fluid Management in Patients Undergoing Cardiac Surgery - Effects of an Acetate Versus Lactate Buffered Balanced Infusion Solution on Hemodynamic Stability, a Randomized Controlled Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period
研究概览
简要总结
Background: Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intra- and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. Despite continuing evaluation no superiority of one particular type of fluid has been reached so far. To the best of the investigators' knowledge no study in humans has ever assessed whether the type of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac performance
Primary Aim: In this study the investigators want to clarify whether a balanced type acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Elective single heart valve replacement
- •Elective double valve replacement
- •Elective single or double valve replacement and coronary artery bypass grafting
排除标准
- •Patients unable to give informed consent
- •Patients younger than 18 years of age or older than 80 years
- •Pregnancy or breastfeeding
- •Ejection fraction (EF) of less than 30% preoperatively
- •Preexisting renal insufficiency with a glomerular filtration rate below 30ml/min
- •Patients transferred form the intensive care unit to the operating theater
- •Emergency operation
- •Reoperation
- •Patients planned for fast-track surgery
- •Patients planned for minimal extracorporal circuits
- •Preexisting anemia requiring immediate perioperative blood transfusion
- •Chronic inflammatory diseases
- •Any signs of infection or sepsis
- •Limitation of full therapy (e.g. Jehowa's witnesses)
研究组 & 干预措施
Ringer lactate
Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
干预措施: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) (Procedure)
Ringer acetate
Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
干预措施: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) (Procedure)
结局指标
主要结局
Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period
时间窗: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
次要结局
- Cumulative dose of inodilators(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))
- Time on inodilators(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))
- Cumulative dose of vasodilatators(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))
- Time on vasodilatators(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))
- Changes in acid-base status(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))
- Time on inopressors(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))
- Total amount of fluid(Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours)))