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

NCT04586218 | Completed

• 1 other identifier: 2019-A03191-56
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative hypotension

  Percentage of treatment period spent with a MAP \< 65 mmHg

  postoperative hour 2

Secondary Outcomes (6)

• Number of vasopressor infusion rate modifications

  postoperative hour 2

• Amount of vasopressor

  postoperative hour 2

• amount of fluid

  postoperative hour 2

• incidence of acute kidney injury

  postoperative day 7

• troponin values

  postoperative day 0

Study Arms (2)

Manual control of vasopressor infusion

ACTIVE COMPARATOR

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

Computer guided vasopressor infusion

EXPERIMENTAL

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

Interventions

Computer guided vasopressor infusion BEHAVIORAL

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

Computer guided vasopressor infusion

Manual control of vasopressor infusion BEHAVIORAL

manual adjustments of noradrenaline infusion

Manual control of vasopressor infusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• Elective cardiac surgery
• French speaking patient

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique de la Sauvegarde: lead
• Bicetre Hospital: collaborator
• Erasme University Hospital: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

Related Publications (1)

• 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.

  PMID: 35061635 DERIVED

Study Officials

• Olivier Desebbe, MD

  Clinique de la Sauvegarde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled superiority trial

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: November 26, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)