Brain InjuriesCOMATNCT03991052
Controlled MAP in the Brain Injury Patient (COMAT Study)
A study testing EV1000 and closed-loop system in people with Brain Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- EV1000 and closed-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2019to 7 Jul 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe brain injury patients (Glasgow score <9), intubated, ventilated and sedated.
Who cannot join
- Glasgow score > 8
- Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)
Read the detailed description
In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management.
After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)
- Conditions
- Brain Injuries
- Being tested
- EV1000 and closed-loop system, Control group
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV1000 and closed-loop systemDevice
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system
Control groupDevice
This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| EV1000 monitor | Active comparator | MAP management will be done as usual (adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system Receives: Device: Control group |
| EV1000 monitor + closed-loop system | Experimental | Fluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration Receives: Device: EV1000 and closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure (MAP)
percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)
Measured: 48 hours post-admission in the intensive care unit
Secondary outcomes (12)
Percentage of case time spent in Hypotension
percentage time spent with MAP below 5 mmHg of the predefined MAP
Measured: 48 hours post-admission in the intensive care unit
Percentage of case time spent Hypertension
percentage time spent with MAP above 5 mmHg of the predefined MAP
Measured: 48 hours post-admission in the intensive care unit
Cerebral perfusion pressure
Measure of Cerebral perfusion pressure during the treatment time (evolution of Cerebral perfusion pressure over time)
Measured: 48 hours post-admission in the intensive care unit
Intracranial pressure
Measure of intracranial pressure during the treatment time (evolution over time)
Measured: 48 hours post-admission in the intensive care unit
Intracranial pressure Hypertension
percentage of intracranial pressure over 20 mmHg during the treatment period
Measured: 48 hours post-admission in the intensive care unit
Fluid received
comparison of amount of fluid received during the treatment period
Measured: 48 hours post-admission in the intensive care unit
Amount of vasopressor
amount of vasopressor received during the treatment period
Measured: 48 hours post-admission in the intensive care unit
Length of stay in the intensive care unit
comparison of the length of stay in the intensive care unit between both groups.
Measured: 30 days post-admission in the intensive care unit
mean arterial pressure (MAP)
MAP over the treatment period
Measured: 48 hours post-admission in the intensive care unit
stroke volume
stroke volume over the treatment period
Measured: 48 hours post-admission in the intensive care unit
cardiac index
cardiac index over the treatment period. This will be the mean values over the procedure. Measurements recorded each 20 seconds and averaged for the procedure. The unit is l/min/m-2
Measured: 48 hours post-admission in the intensive care unit
Transcranial doppler
measure of mean cerebral velocity of mean cerebral artery
Measured: 48 hours post-admission in the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start18 Dec 2019
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- manual versus automated management of MAP
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Jacques DURANTEAU, MD, PhD, Study chair, Bicetre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991052
- Sponsor's protocol ID
- APHP180501
- Acronym
- COMAT
- Status last verified
- May 2023
- First submitted
- 24 May 2019
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03991052
- Acronym / sponsor ID
- COMAT / APHP180501
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, Irvine
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 19 Jun 2019 (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 goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)
Detailed description
In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management.
After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- manual versus automated management of MAP
| Arm | Type | Receives |
|---|---|---|
| EV1000 monitor | Active comparator | Device: Control groupMAP management will be done as usual (adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system |
| EV1000 monitor + closed-loop system | Experimental | Device: EV1000 and closed-loop systemFluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe brain injury patients (Glasgow score <9), intubated, ventilated and sedated.
Key exclusion criteria (2 listed)
- Glasgow score > 8
- Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
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 |
|---|---|---|
| EV1000 and closed-loop systemThis system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system | Device | EV1000 monitor + closed-loop system |
| Control groupThis system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care) | Device | EV1000 monitor |
Primary outcome
Mean arterial pressure (MAP)
Time frame: 48 hours post-admission in the intensive care unit
percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)
12 secondary outcomes
Percentage of case time spent in Hypotension
Time frame: 48 hours post-admission in the intensive care unit
Percentage of case time spent Hypertension
Time frame: 48 hours post-admission in the intensive care unit
Cerebral perfusion pressure
Time frame: 48 hours post-admission in the intensive care unit
Intracranial pressure
Time frame: 48 hours post-admission in the intensive care unit
Intracranial pressure Hypertension
Time frame: 48 hours post-admission in the intensive care unit
Fluid received
Time frame: 48 hours post-admission in the intensive care unit
Amount of vasopressor
Time frame: 48 hours post-admission in the intensive care unit
Length of stay in the intensive care unit
Time frame: 30 days post-admission in the intensive care unit
mean arterial pressure (MAP)
Time frame: 48 hours post-admission in the intensive care unit
stroke volume
Time frame: 48 hours post-admission in the intensive care unit
cardiac index
Time frame: 48 hours post-admission in the intensive care unit
Transcranial doppler
Time frame: 48 hours post-admission in the intensive care unit
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 30 May 2023.
- 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.
Jacques DURANTEAU, MD, PhD study chair
Bicetre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EV1000 and closed-loop system in people with Brain Injuries, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 2 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 30 May 2023. 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?
Mean arterial pressure (MAP) (time frame: 48 hours post-admission in the intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.