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Control Mean Arterial Pressure in the Intensive Care Unit

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04639037
Acronym
COMAP-ICU
Enrollment
53
Registered
2020-11-20
Start date
2021-01-08
Completion date
2022-01-26
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Intraoperative hypotension, intensive care unit, hemodynamic management

Brief summary

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.

Detailed description

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).

Interventions

DEVICEAutomated adjustment of vasopressor

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)

DEVICEManual adjustment of vasopressor

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

Sponsors

University of California, Irvine
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
Erasme University Hospital
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Active comparator (manual adjustment of vasopressor infusion) and Experimental (automated management of vasopressor infusion)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of treatment time with a mean arterial pressure within 80-90 mmHgat DAY 0Percentage of treatment time in target (defined as a mean arterial pressure within 80-90 mmHg)

Secondary

MeasureTime frameDescription
Percentage of treatment time in hypertension (MAP > 90 mmHg)at DAY 0Percentage of treatment time in hypertension (defined as a MAP \> 90 mmHg)
Percentage of treatment time in hypotension (MAP < 80 mmHg)at DAY 0Percentage of treatment time in hypotension (defined as a MAP \< 80 mmHg)
Percentage of treatment time in hypotension (MAP < 65 mmHg)at DAY 0Percentage of treatment time in hypotension (defined as a MAP \< 65 mmHg) which is the usual population target to correct
Amount of vasopressor used during the treatment timeat DAY 0total amount of vasopressor (norepinephrine) used during the treatment time to maintain MAP within 80-90 mmHg
Length of stay in the intensive care unitup to 24 hourslength 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)
Volume of fluid during the treatment timeat DAY 0Volume of fluid during the treatment time

Other

MeasureTime frameDescription
mean Stroke volume index during the treatment timeat DAY 0mean stroke volume index during the treatment time
mean Cardiax index during the treatment timeat DAY 0mean cardiac index during the treatment time

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026