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

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Behavioral: Computer guided vasopressor infusion; Behavioral: Manual control of vasopressor infusion

• Registration Number: NCT04586218
• Lead Sponsor: Clinique de la Sauvegarde

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

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Study Start: 2020-11-26
• Status Verified: 2020-12
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer guided vasopressor 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
Manual control of vasopressor infusion	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

Primary Outcome Measures

Name	Time	Method
incidence of postoperative hypotension	postoperative hour 2	Percentage of treatment period spent with a MAP \< 65 mmHg

Secondary Outcome Measures

Name	Time	Method
amount of fluid	postoperative hour 2	amount of fluid received during surgery
Number of vasopressor infusion rate modifications	postoperative hour 2	Number of vasopressor infusion rate modifications
Amount of vasopressor	postoperative hour 2	Amount of noradrenaline received during surgery
incidence of acute kidney injury	postoperative day 7	incidence of acute kidney injury at postoperative day 7
troponin values	postoperative day 1	troponin values at postoperative day 1

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France