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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

This study has been completed.
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00735631
First received: August 14, 2008
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Device: SISO model-based predictive closed-loop system
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • The propofol and remifentanil dose needed to keep the BIS within the target range [ Time Frame: During sedation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 % [ Time Frame: During sedation ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
 Device: SISO model-based predictive closed-loop system
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735631

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent
Principal Investigator: Annick De Wolf, MD University Hospital, Ghent
Principal Investigator: Johan Decruyenaere, MD, PhD UIniversity Hospital Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00735631     History of Changes
Other Study ID Numbers: 2007/489
Study First Received: August 14, 2008
Last Updated: December 6, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013