Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Acid Base Balance
研究概览
简要总结
Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.
The body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:
How do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?
There will be 4 different groups:
- Ringer-Acetate, 1100 mL / no addition
- Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl)
- Ringer-Acetate, 1100 mL + 160 mmol NaCl
- Plasmalyte, 1100 mL / no addition Blood samples will be taken before, during and after surgery, post operative day 1 and 4 to analyze acid-base balance, electrolytes, and plasma osmolality. Urine output and hydration status will also be collected until post operative day 1. After 3 months, a blood sample will be taken for analysis of electrolytes and kidney function.
详细描述
Cardiopulmonary bypass (CBP) with a heart-lung machine is mandatory for a vast majority of cardiac surgeries. Briefly the disposables in a CPB circuit consists of a reservoir, an oxygenator and tubings.
The role of CPB can be summarized as follows:
- Empty the heart. Drain out the blood (achieved via venous cannulas).
- Oxygenate the blood and remove carbon dioxide. Thus, the lungs are not participating during CPB.
- Maintain homeostasis and adjust chemical and electrolyte blood composition.
- Maintain or adjust the body's temperature via a heat exchanger, which is a part of the heart-lung machine.
- Return oxygenated blood to the patient via arterial cannula.
Heart-lung machine provides even the following:
- Salvage blood loss during surgery via cardiotomy suckers and return it to the patient.
- Prevent distention of the heart during surgery via cardiac vents.
- Deliver cardioplegia which stops the heart, providing myocardial protection and condition to perform cardiac surgery.
- Additional treatments, such as hemofiltration and removing av cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients 18 years and above
- •Undergoing coronary artery bypass graft (CABG) surgery as single surgery
- •Undergoing aortic valve replacement (AVR) as single surgery (AtriClip is allowed)
- •Given consent to participate, both verbal and written
排除标准
- •Subnormal heart function (defined as an ejection fraction <45%), and no signs of heart failure (edema).
- •Body weight <60 kg or >120 kg
- •Preoperative hemoglobin <120 g/L,
- •Subnormal kidney function (defined as GFR <30 ml/min),
- •Blood sodium outside normal range (135-145 mmol/l),
- •Need of acute surgery
- •AVR due to aortic valve insufficiency
- •Changes in operating method or addition of intraoperative procedures.
结局指标
主要结局
Acid Base Balance
时间窗: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative.
This study uses blood samples that are taken at predefined timepoints
Sodium concentration
时间窗: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
This study uses blood samples that are taken at predefined timepoints
Osmolality
时间窗: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 15 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative
This study uses blood samples that are taken at predefined timepoints
次要结局
- Chloride, magnesium -and potassium concentrations(Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.)
- Kidney function(Blood samples will be collected pre operative - the day before surgery or in morning the same day, 1 hour post operative, day 1 and day 4 post operative, and at month 3.)
- Neurological outcome(Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative.)
- Chloride, magnesium -and potassium concentrations(Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.)
- Urine output(Measurements of urine output will be registered during cardiac surgery and 24 hours post operative.)
- Kidney function(Blood samples will be collected pre operative - the day before surgery or in morning the same day, 1 hour post operative, day 1 and day 4 post operative, and at month 3.)
- Neurological outcome(Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative.)