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Completed

NCT Number: NCT04586218

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

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

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer guided vasopressor infusion

Behavioral

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

Manual control of vasopressor infusion

Behavioral

manual adjustments of noradrenaline infusion

Primary outcomes

  1. incidence of postoperative hypotension

    Time frame: postoperative hour 2

    Percentage of treatment period spent with a MAP < 65 mmHg

Secondary outcomes

  1. Number of vasopressor infusion rate modifications

    Time frame: postoperative hour 2

    Number of vasopressor infusion rate modifications

  2. Amount of vasopressor

    Time frame: postoperative hour 2

    Amount of noradrenaline received during surgery

  3. amount of fluid

    Time frame: postoperative hour 2

    amount of fluid received during surgery

  4. incidence of acute kidney injury

    Time frame: postoperative day 7

    incidence of acute kidney injury at postoperative day 7

  5. troponin values

    Time frame: postoperative day 0

    troponin values at intensive care arrival

  6. troponin values

    Time frame: postoperative day 1

    troponin values at postoperative day 1

Sponsors and collaborators

Lead sponsor

Clinique de la Sauvegarde

Other

Collaborators

  • Bicetre Hospital
  • Erasme University Hospital

Registry information

Official study title

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

Acronym: COMAP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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