Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04639037 |
| Other study ID # |
APHP200709 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2021 |
| Est. completion date |
January 26, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
