Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- serum creatinine (s-Cr) concentration
研究概览
简要总结
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential procedure for cardiac surgery, dilutes patient's blood components, possible impact of applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well investigated.
In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years, n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be started at 30 min after anesthesia induction and before CPB application for surgery. In both groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1 hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical, USA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
排除标准
- •preoperative renal failure requiring reran replacement therapy
- •preoperative liver disease
- •preoperative low cardiac output (EF < 50%)
- •Preoperative IABP application, Atrial fibrillation, Pacemaker,
- •contraindication for applying TEE
- •intraoperative withdrawal
研究组 & 干预措施
Active Comparator: Acute normovolemic hemodilution group
Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
干预措施: Acute normovolemic hemodilution (ANH) (Procedure)
Active Comparator: Acute normovolemic hemodilution group
Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
干预措施: hydroxyethyl starch (HES 130/0.6) (Drug)
结局指标
主要结局
serum creatinine (s-Cr) concentration
时间窗: before ANH
次要结局
未报告次要终点
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center
