Manual vs Closed-loop Control of Mean Arterial Pressure
- Conditions
- Hypotension
- Interventions
- Device: closed-loop systemDevice: Manual adjustment
- Registration Number
- NCT04089644
- Lead Sponsor
- Erasme University Hospital
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- Atrial Fibrillation
- Severe Arythmia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description closed-loop group closed-loop system Hypotension will be corrected by closed-loop control of norepinephrine infusion manual group Manual adjustment Hypotension will be corrected by manual infusion of norepinephrine
- Primary Outcome Measures
Name Time Method Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target). 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)
- Secondary Outcome Measures
Name Time Method Uretral perfusion index during the first 15 minutes of the surgery during surgery Mean Uretral perfusion index during the first 15 minutes of the surgery
Amount of fluid received during surgery during surgery Amount of fluid received during surgery
Percentage of case time in target (MAP +/- 10 mmHg) of the chosen MAP target during surgery Percentage of time during surgery with a MAP +/- 10 mmHg of the chosen MAP target.
Stroke volume index during surgery during surgery Mean Stroke volume index during surgery
Uretral perfusion index during the last 15 minutes of the surgery during surgery Mean Uretral perfusion index during the last 15 minutes of the surgery
Cardiac index during surgery during surgery Mean cardiac index during surgery
Stroke volume variation during surgery during surgery Mean Stroke volume variation during surgery
Net fluid balance during surgery during surgery Net fluid balance during surgery
Percentage of case time in hypotension (MAP < 65 mmHg) during surgery Percentage of time during surgery in hypotension using the population target usually admitted and used in clinical studies (MAP \< 65 mmHg)
Amount of vasopressors received during surgery Amount of vasopressors received
Uretral perfusion index during surgery during surgery Mean Uretral perfusion index during surgery using the novel IKORUS urinary catheter recently available on the market
Trial Locations
- Locations (1)
Erasme Hospital
🇧🇪Brussels, Brussel-hoofdstad, Belgium