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

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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Behavioral: Manual control of vasopressor infusion; Behavioral: Computer guided vasopressor infusion

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Manual control of vasopressor infusion; manual adjustments of noradrenaline infusion
Experimental: 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	Behavioral: Computer guided vasopressor infusion; automated titration of vasopressor infusion to maintain a mean arterial pressure > 65mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative hypotension	Percentage of treatment period spent with a MAP < 65 mmHg	postoperative hour 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of vasopressor infusion rate modifications	Number of vasopressor infusion rate modifications	postoperative hour 2
Amount of vasopressor	Amount of noradrenaline received during surgery	postoperative hour 2
amount of fluid	amount of fluid received during surgery	postoperative hour 2
incidence of acute kidney injury	incidence of acute kidney injury at postoperative day 7	postoperative day 7
troponin values	troponin values at intensive care arrival	postoperative day 0
troponin values	troponin values at postoperative day 1	postoperative day 1

Collaborators and Investigators

• Sponsor: Clinique de la Sauvegarde
• Collaborators: Bicetre Hospital; Erasme University Hospital
• Investigators: Principal Investigator: Olivier Desebbe, MD, Clinique de la Sauvegarde

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasoconstrictor Agents
• Other Study ID Numbers: 2019-A03191-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No