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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04089644
Enrollment
30
Registered
2019-09-13
Start date
2019-09-17
Completion date
2020-03-05
Last updated
2020-03-10

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

Conditions

Hypotension

Brief summary

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): 1. Control group = standard practice ( manually adjusted norepinephrine infusion to correct hypotension and keep MAP within 90% of patient's baseline MAP 2. 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

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)

Interventions

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)

DEVICEManual adjustment

Vasopressor agents will be manually adjusted (standard practice). Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)

Sponsors

University of California, Los Angeles
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
Bicetre Hospital
CollaboratorOTHER
Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Single center prospective randomized controlled trial

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target).At postoperative day 1Undertreatment. Percentage of time during surgery in hypotension. The MAP used to define hypotension will differ for each patient (individualized approach)

Secondary

MeasureTime frameDescription
Percentage of case time in target (MAP +/- 10 mmHg) of the chosen MAP targetduring surgeryPercentage of time during surgery with a MAP +/- 10 mmHg of the chosen MAP target.
Amount of vasopressors receivedduring surgeryAmount of vasopressors received
Uretral perfusion index during surgeryduring surgeryMean Uretral perfusion index during surgery using the novel IKORUS urinary catheter recently available on the market
Uretral perfusion index during the first 15 minutes of the surgeryduring surgeryMean Uretral perfusion index during the first 15 minutes of the surgery
Uretral perfusion index during the last 15 minutes of the surgeryduring surgeryMean Uretral perfusion index during the last 15 minutes of the surgery
Percentage of case time in hypotension (MAP < 65 mmHg)during surgeryPercentage of time during surgery in hypotension using the population target usually admitted and used in clinical studies (MAP \< 65 mmHg)
Stroke volume index during surgeryduring surgeryMean Stroke volume index during surgery
Stroke volume variation during surgeryduring surgeryMean Stroke volume variation during surgery
Amount of fluid received during surgeryduring surgeryAmount of fluid received during surgery
Net fluid balance during surgeryduring surgeryNet fluid balance during surgery
Cardiac index during surgeryduring surgeryMean cardiac index during surgery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026