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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 24, 2014