Controling Mean Arterial Pressure Using a Closed-Loop System for Vasopressor Titration
NCT ID: NCT04586218
Last Updated: 2020-12-22
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.
COMPLETED
NA
40 participants
INTERVENTIONAL
2020-11-26
2020-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
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
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Manual control of vasopressor infusion
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
Manual control of vasopressor infusion
manual adjustments of noradrenaline infusion
Computer guided vasopressor infusion
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
Computer guided vasopressor infusion
automated titration of vasopressor infusion to maintain a mean arterial pressure \> 65mmHg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Computer guided vasopressor infusion
automated titration of vasopressor infusion to maintain a mean arterial pressure \> 65mmHg
Manual control of vasopressor infusion
manual adjustments of noradrenaline infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective cardiac surgery
* French speaking patient
Exclusion Criteria
* Renal insufficiency (estimated glomerular filtration rate \< 30mL/min/1,73m²)
* Left ejection fraction \< 40%
* Emergency surgery
* Preoperative infection
* Preoperative cardiac arrythmia
* Pregnant women
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bicetre Hospital
OTHER
Erasme University Hospital
OTHER
Clinique de la Sauvegarde
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olivier Desebbe, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique de la Sauvegarde
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique de la Sauvegarde
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-A03191-56
Identifier Type: -
Identifier Source: org_study_id