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Completed

NCT Number: NCT04639037

Control Mean Arterial Pressure in the Intensive Care Unit

The goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. The investigators hypothesis is that the automated group will spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual group.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bicêtre Hospital, Le Kremlin-Bicêtre, France

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About this study

Although the correction of hypotension during the perioperative period should be a key goal, approximately 40% of overall mortality is still closely linked to the presence of perioperative hypotension which is responsible for significant morbidity particularly in patients undergoing major surgery. Indeed, inadequate management of perioperative hypotension remains an undeniable risk factor for morbidity and mortality. However, management of perioperative mean arterial pressure (MAP) is still suboptimal today. Indeed, the analysis of our database demonstrates that, on average, patient spends only 50-60 % of the treatment time within the predetermined MAP target. In about 10% of the treatment time, the patient is under-treated (hypotension) and 30% of the time, the patient is over-treated (hypertension).

The correction of hypotension is achieved using vasopressor drugs (mainly norepinephrine infusion). In 2017 a study published in the JAMA shows that patients with tightly controlled arterial pressure have fewer organ dysfunctions than those with standard blood pressure management. However, maintaining MAP within a narrow range involves regular manual adjustments of norepinephrine infusion doses by intensive care unit nurses. When a hypotension occurs, there is usually two main possible treatments (fluid or vasopressors). In the operating room, for patients undergoing major surgery, we usually optimize fluid and vasopressor titration using an advanced hemodynamic monitoring device "EV1000 monitor" (Edwards Lifesciences, Irvine USA).This monitoring device can also be connected to a computer that controls a norepinephrine infusion pump in order to tightly adjust the infusion of norepinephrine to the target MAP predetermined by the clinician in charge of the patients. We have recently demonstrated that the use of such system resulted in less intraoperative time in hypotension compared to manual management. However, in the postoperative period, in patients admitted in the intensive care unit after a major surgery and requiring tight control of MAP, such demonstration is still lacking.

Therefore, the objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care unit or post-anesthesia care unit after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a predetermined MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Patients (>18 years)
  • Patients in the intensive care or post-anesthesia care unit after a major surgery and requiring norepinephrine infusion to maintain a MAP of 80-90 mmHg.
  • Patients equipped with an advanced hemodynamic monitoring device as standard of care during the surgery.
  • Patient with a social security number

Exclusion criteria

  • Patients refusing to participate

Treatment and study plan

Automated adjustment of vasopressor

Device

The objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration)

Manual adjustment of vasopressor

Device

Fluid and vasopressor will be delivered as standard of care (manual adjustment of both fluid and vasopressor infusion rate by the nurse)

Primary outcomes

  1. Percentage of treatment time with a mean arterial pressure within 80-90 mmHg

    Time frame: at DAY 0

    Percentage of treatment time in target (defined as a mean arterial pressure within 80-90 mmHg)

Secondary outcomes

  1. Percentage of treatment time in hypertension (MAP > 90 mmHg)

    Time frame: at DAY 0

    Percentage of treatment time in hypertension (defined as a MAP > 90 mmHg)

  2. Percentage of treatment time in hypotension (MAP < 80 mmHg)

    Time frame: at DAY 0

    Percentage of treatment time in hypotension (defined as a MAP < 80 mmHg)

  3. Percentage of treatment time in hypotension (MAP < 65 mmHg)

    Time frame: at DAY 0

    Percentage of treatment time in hypotension (defined as a MAP < 65 mmHg) which is the usual population target to correct

  4. Volume of fluid during the treatment time

    Time frame: at DAY 0

    Volume of fluid during the treatment time

  5. Amount of vasopressor used during the treatment time

    Time frame: at DAY 0

    total amount of vasopressor (norepinephrine) used during the treatment time to maintain MAP within 80-90 mmHg

  6. Length of stay in the intensive care unit

    Time frame: up to 24 hours

    length of stay in the intensive care unit (discharge at the discretion of the clinician in charge of the patient and not involved in the study protocol)

Other outcomes

  1. mean Stroke volume index during the treatment time

    Time frame: at DAY 0

    mean stroke volume index during the treatment time

  2. mean Cardiax index during the treatment time

    Time frame: at DAY 0

    mean cardiac index during the treatment time

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Erasme University Hospital
  • University of California, Irvine
  • University of California, Los Angeles

Registry information

Official study title

Tight Postoperative Control of Mean Arterial Pressure Using a Closed-loop System for Norepinephrine Administration: A Randomized Controlled Trial in Patients Admitted to the Intensive Care Unit After a Major Surgery.

Acronym: COMAP-ICU

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2020
Registry last updated
May 3, 2022

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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