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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006217-16-BE
Enrollment
Unknown
Registered
2007-11-21
Start date
2007-12-14
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery (OPCAB)

Interventions

Trade Name: Diprivan 1% Product Name: Propofol Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Propofol CAS Number: 2078548 Concentration unit: % percent Concentration type: equal Conc

Sponsors

University Hospital Ghent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 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

Design outcomes

Primary

MeasureTime frame
Main Objective: 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 sedation. ;Secondary Objective: To evaluate the interaction of propofol and remifentanil ;Primary end point(s): The primary end point of this study is the propofol and remifentanil dose needed to keep the BIS within the target range. Secundary end point is the hemodynamic stability of the patient.—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026