Clinical trial NCT00735631: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2008-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 sedation.


Eligibility criteria: Inclusion Criteria:

* patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
* age \>= 18 years
* informed consent obtained before the surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: The propofol and remifentanil dose needed to keep the BIS within the target range
timeFrame: During sedation
Secondary outcomes:
measure: The hemodynamic stability of the patient, being defined as: - mean arterial blood pressure between 65 and 85 - heart rate around 80 beats'/min - diuresis 0.5 - 1 ml/kg/hour - normal pH - normal cardiac index as defined by a CI > 2.2 - Sv02 > 60 %
timeFrame: During sedation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Michel Struys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Annick De Wolf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UIniversity Hospital Ghent
name: Johan Decruyenaere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neckebroek M, Ionescu CM, van Amsterdam K, De Smet T, De Baets P, Decruyenaere J, De Keyser R, Struys MMRF. A comparison of propofol-to-BIS post-operative intensive care sedation by means of target controlled infusion, Bayesian-based and predictive control methods: an observational, open-label pilot study. J Clin Monit Comput. 2019 Aug;33(4):675-686. doi: 10.1007/s10877-018-0208-2. Epub 2018 Oct 11.