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Controling Mean Arterial Pressure Using a Closed-Loop System for Vasopressor Titration

Postoperative Hypotension Management With Computer-guided Vasopressor Titration in High-Risk Patients After Cardiac Surgery: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04586218
Acronym
COMAP
Enrollment
40
Registered
2020-10-14
Start date
2020-11-26
Completion date
2020-12-17
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Brief 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. 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

Interventions

BEHAVIORALComputer guided vasopressor infusion

automated titration of vasopressor infusion to maintain a mean arterial pressure \> 65mmHg

BEHAVIORALManual control of vasopressor infusion

manual adjustments of noradrenaline infusion

Sponsors

Bicetre Hospital
CollaboratorOTHER
Erasme University Hospital
CollaboratorOTHER
Clinique de la Sauvegarde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomized controlled superiority trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Adult patient * Elective cardiac surgery * French speaking patient

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
incidence of postoperative hypotensionpostoperative hour 2Percentage of treatment period spent with a MAP \< 65 mmHg

Secondary

MeasureTime frameDescription
Number of vasopressor infusion rate modificationspostoperative hour 2Number of vasopressor infusion rate modifications
Amount of vasopressorpostoperative hour 2Amount of noradrenaline received during surgery
amount of fluidpostoperative hour 2amount of fluid received during surgery
incidence of acute kidney injurypostoperative day 7incidence of acute kidney injury at postoperative day 7
troponin valuespostoperative day 0troponin values at intensive care arrival

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026