Coronary Artery DiseasePhase 4NCT00735631
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
A Phase 4 study testing SISO model-based predictive closed-loop system in people with Coronary Artery Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SISO model-based predictive closed-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
- age >= 18 years
- informed consent obtained before the surgery
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Coronary Artery Disease
- Being tested
- SISO model-based predictive closed-loop system
- Keywords
- Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SISO model-based predictive closed-loop systemDevice
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol Receives: Device: SISO model-based predictive closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The propofol and remifentanil dose needed to keep the BIS within the target range
Measured: During sedation
Secondary outcomes (1)
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 %
Measured: During sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Sponsor
- Investigators
- Michel Struys, MD, PhD, Principal investigator, University Hospital, GhentAnnick De Wolf, MD, Principal investigator, University Hospital, GhentJohan Decruyenaere, MD, PhD, Principal investigator, UIniversity Hospital Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735631
- Sponsor's protocol ID
- 2007/489
- Status last verified
- Dec 2011
- First submitted
- 14 Aug 2008
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30311073
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00735631
- Acronym / sponsor ID
- 2007/489
- Conditions
- Coronary Artery Disease
- Keywords
- Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SISO model-based predictive closed-loop systemThe single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
- age >= 18 years
- informed consent obtained before the surgery
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SISO model-based predictive closed-loop systemThe single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol | Device | 1 |
Primary outcome
The propofol and remifentanil dose needed to keep the BIS within the target range
Time frame: During sedation
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
- Derived from this study: PubMed 30311073Neckebroek 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.
- Website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Struys, MD, PhD principal investigator
University Hospital, Ghent
Annick De Wolf, MD principal investigator
University Hospital, Ghent
Johan Decruyenaere, MD, PhD principal investigator
UIniversity Hospital Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SISO model-based predictive closed-loop system in people with Coronary Artery Disease, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The propofol and remifentanil dose needed to keep the BIS within the target range (time frame: During sedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.