EUCTR2007-006217-16-BE进行中（未招募）不适用
Evaluation of the accuracy, safety and robustness of a single-input-single output (SISO) model-based predictive closed-loop system to guide patient-individualized ICU sedation.
niversity Hospital Ghent0 个研究点开始时间: 2007年11月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- patients in the immediate post-operatieve phase after coronary artery reconstruction surgery (OPCAB).
- •- age > or = 18 years
- •- informed consent obtained before the surgery
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with :
- •- severe renal failure defined by the RIFLE Classification levels Risk, Failure and End-stage Kidney Failure
- •- severe hepatic failure defined by a bilirubin level of > or = 3 mg/dl and/or a prothrombin level of < 50% before the surgery
- •- low ejection fraction defined as < 40%
- •- age < 18 years
- •- postoperative bleeding so that a new surgery is necessary
- •- history of cerebrovasculair accident (CVA)
- •- history of COPD
- •- age > 75 years
- •- postoperative cardiac index < 2.2 for more than 2 hours
- •- SvO2 < 60% for more than 2 hours
- •- hypotension with a MAP < 60 mmHg for more than 2 hours
- •- sedation agents other than remifentanyl and propofol including also Catapressan, Risperdal, Etumine
- •- Remifentanyl dose exceeding 0.5 µg/kg/min
- •- absence of informed consent
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