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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2019-04-01
2019-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
NCT04900168
TBI Multimodal Monitoring Study
NCT02993549
Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury
NCT01291706
Study to Improve Outcomes for Survivors of Traumatic Brain Injury in Latin America
NCT01068522
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury
NCT02911675
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.
The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
EV1000 and closed-loop system
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EV1000 and closed-loop system
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Bilateral mydriasis at the initial management
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bicetre Hospital
OTHER
University of California, Irvine
OTHER
University of California, Los Angeles
OTHER
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alexandre Joosten
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacques Duranteau, PhD
Role: STUDY_DIRECTOR
APHP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Joosten Alexandre
Paris, LE Kremlin Bicetre, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-A02976-49
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.