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临床试验/NCT02831270
NCT02831270已完成不适用

Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Konkuk University Medical Center

研究点 (1)

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