Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586218
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2020-10-07
Brief Title:
Controling Mean Arterial Pressure Using a Closed-Loop System for Vasopressor Titration
Sponsor:
Clinique de la Sauvegarde
Organization:
Clinique de la Sauvegarde
Study Overview
Official Title:
Postoperative Hypotension Management With Computer-guided Vasopressor Titration in High-Risk Patients After Cardiac Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMAP
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
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 ie 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 egnoradrenaline in order to maintain MAP within a narrow range in the perioperative setting The investigators have published engineering animal and most recently pilotstudies 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
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 ie 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 egnoradrenaline in order to maintain MAP within a narrow range in the perioperative setting The investigators have published engineering animal and most recently pilotstudies 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None