Controlled MAP in the Brain Injury Patient (COMAT Study)
NCT ID: NCT03991052
Last Updated: 2023-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2019-12-18
2021-07-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EV1000 monitor
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
Control group
This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
EV1000 monitor + closed-loop system
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
EV1000 and closed-loop system
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system
Interventions
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EV1000 and closed-loop system
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system
Control group
This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
18 Years
99 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
University of California, Irvine
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jacques DURANTEAU, MD, PhD
Role: STUDY_CHAIR
Bicetre
Locations
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Bicêtre hospital
Le Kremlin-Bicêtre, , France
Countries
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Other Identifiers
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APHP180501
Identifier Type: -
Identifier Source: org_study_id
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