Control Mean Arterial Pressure in the Intensive Care Unit (COMAP-ICU)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hypotension

Treatments: Device: Automated adjustment of vasopressor; Device: Manual adjustment of vasopressor

Study type: Interventional

Funder types: Other

Identifiers

NCT04639037

APHP200709

Details and patient eligibility

About

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.

Full 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).

Enrollment: 53 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Manual adjustment of vasopressor

Active Comparator group

Description:

Fluid and vasopressor will be managed as standard practice guided by the EV1000 monitoring device (manually infusion of both fluid and vasopressors) Objective being to maintain MAP within a target MAP range of 80-90 mmHg (fluid will be optimized and stroke volume index will be maintained within normal values)

Treatment:

Device: Manual adjustment of vasopressor

Automated adjustment of vasopressor

Experimental group

Description:

Fluid will be managed using the EV1000 monitoring in order to optimize stroke volume index and vasopressor will be automatically deliver by a closed-loop system to maintain the MAP within the target range of 80-90 mmHg

Treatment:

Device: Automated adjustment of vasopressor