- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089644
Manual vs Closed-loop Control of Mean Arterial Pressure
Physician-Directed vs Computer-Assisted Norepinephrine Administration in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial
Intraoperative hypotension can impact patient outcome. Vasopressors are usually used to correct hypotension and ensure adequate organ perfusion.
The investigators have recently developed an automated system (closed-loop system) to titrate vasopressor agents in surgical and intensive care patients.
The purpose of this study is to compare two strategies to correct hypotension based on an individual definition of hypotension (therefore, the target MAP used to define hypotension will differ for each patient (individualized approach):
- Control group = standard practice ( manually adjusted norepinephrine infusion to correct hypotension and keep MAP within 90% of patient's baseline MAP
- Intervention group = closed-loop (automated) vasopressor administration system will deliver norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac, Edwards Lifesciences, IRVINE, USA) to correct hypotension and keep MAP within 90% of patient's baseline MAP
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In order to prevent the known postoperative complications of intraoperative hypotension, vasopressor agents are occasionally used to ensure adequate perfusion. These vasopressors are usually administered as manually adjusted infusions, but this practice requires considerable time and attention.
To overcome this issue, the investigators have developed a closed-loop vasopressor (CLV) controller to potentially correct hypotension more efficiently. After completing extensive in-silico, in-vivo studies and a pilot human trial in a small cohort of 20 patients, the investigators aimed to conduct now a randomized control trial comparing manual vasopressor adjustment versus closed-loop vasopressor adjustment in high risk patients undergoing major abdominal surgeries in order to correct hypotension during surgery
The primary outcome will be the incidence of hypotension (defined as a reduction of > 10% from patient's MAP target, or a allowed tolerance of 10% reduction from patient's baseline MAP). This has been chosen based on the recent study of Emmanuel Futier and colleagues (Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357), even if it was originally done with systolic blood pressure
Participants in both groups will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of vasopressor administration.
Fluids will be standardized in both groups and will be given as a continuous baseline infusion of 3 ml/kg/h (balanced crystalloid solution) and additional fluid boluses (mini fluid challenges of 100 ml) as a goal directed fluid therapy strategy to maintain stroke volume variation < 13%. The only difference is the way norepinephrine is delivered to the patient (manual versus closed-loop assisted)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussel-hoofdstad
-
Brussels, Brussel-hoofdstad, Belgium, 1070
- Erasme hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- High-risk adult patients undergoing major abdominal surgeries requiring an advanced cardiac output monitoring device (EV1000-Edwards LifeSciences, Irvine, USA) and a tight blood pressure control
Exclusion Criteria:
- Atrial Fibrillation
- Severe Arythmia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: manual group
Hypotension will be corrected by manual infusion of norepinephrine
|
Vasopressor agents will be manually adjusted (standard practice). Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA) |
EXPERIMENTAL: closed-loop group
Hypotension will be corrected by closed-loop control of norepinephrine infusion
|
Hypotension will be corrected by an automated system for vasopressor administration. Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target).
Time Frame: At postoperative day 1
|
Undertreatment.
Percentage of time during surgery in hypotension.
The MAP used to define hypotension will differ for each patient (individualized approach)
|
At postoperative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of case time in hypotension (MAP < 65 mmHg)
Time Frame: during surgery
|
Percentage of time during surgery in hypotension using the population target usually admitted and used in clinical studies (MAP < 65 mmHg)
|
during surgery
|
Percentage of case time in target (MAP +/- 10 mmHg) of the chosen MAP target
Time Frame: during surgery
|
Percentage of time during surgery with a MAP +/- 10 mmHg of the chosen MAP target.
|
during surgery
|
Amount of vasopressors received
Time Frame: during surgery
|
Amount of vasopressors received
|
during surgery
|
Uretral perfusion index during surgery
Time Frame: during surgery
|
Mean Uretral perfusion index during surgery using the novel IKORUS urinary catheter recently available on the market
|
during surgery
|
Uretral perfusion index during the first 15 minutes of the surgery
Time Frame: during surgery
|
Mean Uretral perfusion index during the first 15 minutes of the surgery
|
during surgery
|
Uretral perfusion index during the last 15 minutes of the surgery
Time Frame: during surgery
|
Mean Uretral perfusion index during the last 15 minutes of the surgery
|
during surgery
|
Cardiac index during surgery
Time Frame: during surgery
|
Mean cardiac index during surgery
|
during surgery
|
Stroke volume index during surgery
Time Frame: during surgery
|
Mean Stroke volume index during surgery
|
during surgery
|
Stroke volume variation during surgery
Time Frame: during surgery
|
Mean Stroke volume variation during surgery
|
during surgery
|
Amount of fluid received during surgery
Time Frame: during surgery
|
Amount of fluid received during surgery
|
during surgery
|
Net fluid balance during surgery
Time Frame: during surgery
|
Net fluid balance during surgery
|
during surgery
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2019/347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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