The Efficacy and Safety of 7.2% NaCl Plus 6% Hydroxyethyl 200/0.5 in Patients Scheduled for First-time Coronary Artery Bypass Grafting With Cardiopulmonary Bypass.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Extravascular Lung Water Index
研究概览
简要总结
The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.
Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.
The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass
排除标准
- •age >70 years
- •body mass index <18 and >35 kg/m2
- •left ventricular ejection fraction <40%
- •myocardial infarction <6 months before surgery
- •stroke or transient ischemic attack <12 months before surgery
- •diabetes mellitus
- •glomerular filtration rate <90 mL/min
- •emergency surgery
- •hematocrit <30%.
研究组 & 干预措施
7.2% NaCl /hydroxyethyl starch 200/0.5
On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
干预措施: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 (Drug)
0.9% NaCl
On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
Extravascular Lung Water Index
时间窗: baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1
Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".
次要结局
- Pulmonary Oxygenation(24 hours)
- Oxygen Delivery(24 hours)
- Cardiac Index(24 hours)
- Fluid Balance(24 hours)
- Inflammation Response(24 hours)
- Endothelial Integrity(24 hours)
- Plasma Na(24 hours)
- Plasma Osmolarity(24 hours)
- Rate of Acute Kidney Injury(48 hours)
- Rate of Hyperchloremic Metabolic Acidosis(24 hours)
- Stroke Volume Index(24 hours)
- Rate of Neurological Complications(24 hours)
- Blood Loss(24 hours)
- Duration of Mechanical Ventilation(24 hours)
- Chloride Loading(24 h)
研究者
Evgeny Fominskiy, MD, PhD
Anesthesiologist
Meshalkin Research Institute of Pathology of Circulation