EUCTR2007-006217-16-BE
Active, Not Recruiting
N/A
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 sitesNovember 21, 2007
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital Ghent
- Status
- Active, Not Recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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