Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Agentschap voor Innovatie door Wetenschap en Technologie
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The aim of this study is to investigate the accuracy, safety and robustness of a single-input-single output (SISO) model-based predictive closed-loop system to guide patient-individualized ICU sedatio...
Eligibility Criteria
Inclusion
- patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
- age \>= 18 years
- informed consent obtained before the surgery
Exclusion
- 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 \>= 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 cardiovascular 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00735631
Start Date
June 1 2008
End Date
October 1 2009
Last Update
December 7 2011
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000