Cardiac SurgeryCOMAPNCT04586218
Controling Mean Arterial Pressure Using a Closed-Loop System for Vasopressor Titration
A study testing Computer guided vasopressor infusion in people with Cardiac Surgery, run by Clinique de la Sauvegarde at 1 site in France.
Trial summary
The investigators have developed an automated vasopressor controller to improve the titration of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and have recently shown the controller was effective in both the operating room and intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Computer guided vasopressor infusion
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2020to 17 Dec 2020
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Elective cardiac surgery
- French speaking patient
Who cannot join
- Uncontrolled hypertension
- Renal insufficiency (estimated glomerular filtration rate < 30mL/min/1,73m²)
- Left ejection fraction < 40%
- Emergency surgery
- Preoperative infection
- Preoperative cardiac arrythmia
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Hypotension Management With Computer-guided Vasopressor Titration in High-Risk Patients After Cardiac Surgery: A Randomized Controlled Trial
The investigators have developed an automated vasopressor controller to improve the titration of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and have recently shown the controller was effective in both the operating room and intensive care unit. The controller has been used recently in a case series of three patients undergoing cardiac surgery and in five patients after cardiac surgery.
The investigators want to compare now a manual to a closed-loop titration of vasopressor infusion in patients admitted in the Intensive Care unit after cardiac surgery
Read the detailed description
Perioperative hypotension and arterial pressure variability have been shown to negatively impact patient outcomes, increasing risk of stroke, kidney injury, and myocardial injury among others.
Vasopressors are usually used to rapidly correct hypotension. Vasopressor infusions are typically administered by standard infusion pump with the rate adjusted by anesthesiologists to reach a predefined target mean arterial pressure (MAP); this requires frequent changes in the infusion rate because of the almost constantly changing hemodynamic status of such patients. Because it is infeasible for human providers to pay constant attention and make second-to-second changes, management is often suboptimal (i.e. large amounts of time are spent in hypotension below the target, or well above the target with the vasopressor drip still running).
The investigators have developed an automated closed-loop vasopressor (CLV) controller to improve the titration of vasopressor (e.g:noradrenaline) in order to maintain MAP within a narrow range in the perioperative setting. The investigators have published engineering, animal and most recently, pilot,studies or case series with promising results.
In this randomized controlled trial, the investigators will compare time spent in hypotension defined as a mean arterial pressure < 65 mmHg. They tested the hypothesis that the automated system will allow patients to spent less time during the postoperative period with a MAP < 65 mmHg. This is thus a superiority study over a two hours study period
- Conditions
- Cardiac Surgery
- Being tested
- Computer guided vasopressor infusion, Manual control of vasopressor infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided vasopressor infusionBehavioural
automated titration of vasopressor infusion to maintain a mean arterial pressure > 65mmHg
Manual control of vasopressor infusionBehavioural
manual adjustments of noradrenaline infusion
| Study group | Role | What they receive |
|---|---|---|
| Manual control of vasopressor infusion | Active comparator | Vasopressor will be manually titrated by intensive care unit nurses in charge of the patients to maintain mean arterial pressure > 65 mmHg.
Fluid administration consists in optimization of stroke volume (assisted fluid management) during the postoperative period Receives: Behavioral: Manual control of vasopressor infusion |
| Computer guided vasopressor infusion | Experimental | Vasopressor will be titrated automatically by the closed-loop system to maintain mean arterial pressure > 65 mmHg.
Fluid administration consists in optimization of stroke volume (assisted fluid management) during the postoperative period Receives: Behavioral: Computer guided vasopressor infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative hypotension
Percentage of treatment period spent with a MAP < 65 mmHg
Measured: postoperative hour 2
Secondary outcomes (6)
Number of vasopressor infusion rate modifications
Number of vasopressor infusion rate modifications
Measured: postoperative hour 2
Amount of vasopressor
Amount of noradrenaline received during surgery
Measured: postoperative hour 2
amount of fluid
amount of fluid received during surgery
Measured: postoperative hour 2
incidence of acute kidney injury
incidence of acute kidney injury at postoperative day 7
Measured: postoperative day 7
troponin values
troponin values at intensive care arrival
Measured: postoperative day 0
troponin values
troponin values at postoperative day 1
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start26 Nov 2020
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
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 Cardiac SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled superiority trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique de la Sauvegarde
- Sponsor type
- University, hospital or other
- Collaborators
- Bicetre Hospital, Erasme University Hospital
- Responsible party
- Sponsor
- Investigators
- Olivier Desebbe, MD, Principal investigator, Clinique de la Sauvegarde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586218
- Sponsor's protocol ID
- 2019-A03191-56
- Acronym
- COMAP
- Status last verified
- Dec 2020
- First submitted
- 7 Oct 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desebbe O, Rinehart J, Van der Linden P, Cannesson M, Delannoy B, Vigneron M, Curtil A, Hautin E, Vincent JL, Duranteau J, Joosten A. Control of Postoperative Hypotension Using a Closed-Loop System for Norepinephrine Infusion in Patients After Cardiac Surgery: A Randomized Trial. Anesth Analg. 2022 May 1;134(5):964-973. doi: 10.1213/ANE.0000000000005888.
PubMed 35061635
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypotension Management With Computer-guided Vasopressor Titration in High-Risk Patients After Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04586218
- Acronym / sponsor ID
- COMAP / 2019-A03191-56
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinique de la SauvegardeUniversity, hospital or other
- Collaborators
- Bicetre Hospital, Erasme University Hospital
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 14 Oct 2020 (actual)
- 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 investigators have developed an automated vasopressor controller to improve the titration of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and have recently shown the controller was effective in both the operating room and intensive care unit. The controller has been used recently in a case series of three patients undergoing cardiac surgery and in five patients after cardiac surgery.
The investigators want to compare now a manual to a closed-loop titration of vasopressor infusion in patients admitted in the Intensive Care unit after cardiac surgery
Detailed description
Perioperative hypotension and arterial pressure variability have been shown to negatively impact patient outcomes, increasing risk of stroke, kidney injury, and myocardial injury among others.
Vasopressors are usually used to rapidly correct hypotension. Vasopressor infusions are typically administered by standard infusion pump with the rate adjusted by anesthesiologists to reach a predefined target mean arterial pressure (MAP); this requires frequent changes in the infusion rate because of the almost constantly changing hemodynamic status of such patients. Because it is infeasible for human providers to pay constant attention and make second-to-second changes, management is often suboptimal (i.e. large amounts of time are spent in hypotension below the target, or well above the target with the vasopressor drip still running).
The investigators have developed an automated closed-loop vasopressor (CLV) controller to improve the titration of vasopressor (e.g:noradrenaline) in order to maintain MAP within a narrow range in the perioperative setting. The investigators have published engineering, animal and most recently, pilot,studies or case series with promising results.
In this randomized controlled trial, the investigators will compare time spent in hypotension defined as a mean arterial pressure < 65 mmHg. They tested the hypothesis that the automated system will allow patients to spent less time during the postoperative period with a MAP < 65 mmHg. This is thus a superiority study over a two hours study period
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Manual control of vasopressor infusion | Active comparator | Behavioral: Manual control of vasopressor infusionVasopressor will be manually titrated by intensive care unit nurses in charge of the patients to maintain mean arterial pressure > 65 mmHg. Fluid administration consists in optimization of stroke volume (assisted fluid management) during the postoperative period |
| Computer guided vasopressor infusion | Experimental | Behavioral: Computer guided vasopressor infusionVasopressor will be titrated automatically by the closed-loop system to maintain mean arterial pressure > 65 mmHg. Fluid administration consists in optimization of stroke volume (assisted fluid management) during the postoperative period |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- Elective cardiac surgery
- French speaking patient
Key exclusion criteria (7 listed)
- Uncontrolled hypertension
- Renal insufficiency (estimated glomerular filtration rate < 30mL/min/1,73m²)
- Left ejection fraction < 40%
- Emergency surgery
- Preoperative infection
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 |
|---|---|---|
| Computer guided vasopressor infusionautomated titration of vasopressor infusion to maintain a mean arterial pressure > 65mmHg | Behavioural | Computer guided vasopressor infusion |
| Manual control of vasopressor infusionmanual adjustments of noradrenaline infusion | Behavioural | Manual control of vasopressor infusion |
Primary outcome
incidence of postoperative hypotension
Time frame: postoperative hour 2
Percentage of treatment period spent with a MAP < 65 mmHg
6 secondary outcomes
Number of vasopressor infusion rate modifications
Time frame: postoperative hour 2
Amount of vasopressor
Time frame: postoperative hour 2
amount of fluid
Time frame: postoperative hour 2
incidence of acute kidney injury
Time frame: postoperative day 7
troponin values
Time frame: postoperative day 0
troponin values
Time frame: postoperative day 1
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 22 Dec 2020.
- Derived from this study: PubMed 35061635Desebbe O, Rinehart J, Van der Linden P, Cannesson M, Delannoy B, Vigneron M, Curtil A, Hautin E, Vincent JL, Duranteau J, Joosten A. Control of Postoperative Hypotension Using a Closed-Loop System for Norepinephrine Infusion in Patients After Cardiac Surgery: A Randomized Trial. Anesth Analg. 2022 May 1;134(5):964-973. doi: 10.1213/ANE.0000000000005888.
- Individual participant dataSharing planned: No
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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.
Olivier Desebbe, MD principal investigator
Clinique de la Sauvegarde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided vasopressor infusion in people with Cardiac Surgery, run by Clinique de la Sauvegarde at 1 site in France.
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 7 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 22 Dec 2020. 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 France. 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.
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?
incidence of postoperative hypotension (time frame: postoperative hour 2). 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 NCT04586218, 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 22 Dec 2020.