Hemodynamic (MAP) Stability
Conditions
Brief summary
Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients. The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension. After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery
Detailed description
Intraoperative hypotension is frequent in patients undergoing surgery and can negatively impact organ perfusion. The investigators have developed a closed-loop vasopressor (CLV) controller to more efficiently correct hypotension. The investigators tested it extensively in preclinical studies and recently demonstrated its feasibility and excellent performance metrics in a short series of high-risk patients undergoing major surgical procedures. In these studies, the controller was linked to a minimally-invasive advanced hemodynamic monitoring device utilizing an arterial line which then controlled a vasopressor infusion. However, the vast majority of patients who undergo surgery do not require an arterial line but should still benefit from rapid corrections of hypotensive episodes that are less rapidly detected via an intermittent non-invasive blood pressure cuff. Fortunately, completely noninvasive technology now allows us to continuously monitor blood pressure and therefore extend the use of our closed-loop vasopressor system to patients in whom an arterial catheter would not typically be placed. Patients undergoing renal transplant surgeries are the ideal patient population. The investigators aimed to test the feasibility of guiding our CLV controller with a continuous noninvasive blood pressure monitoring device (ClearSight system, Edwards Lifesciences, Irvine, CA, USA) in three patients (case series)
Interventions
DEVICEClosed-loop system
the CLV system will correct hypotension by automated adjustment of norepinephrine.
Sponsors
University of California, Los Angeles
University of California, Irvine
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single prospective pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Adult high risk patients undergoing renal transplant surgery 2. Patients equipped with a clearsight advanced hemodynamic monitoring system
Exclusion criteria
1. Atrial fibrillation 2. No consent obtained from the patient. 3. Ejection fraction \< 30%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of case time in hypotension | during surgery | % of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of active treatment time spent in a hypertensive state | during surgery | Percentage of active treatment time spent in a hypertensive state, defined as a MAP \>5mmHg above the chosen target MAP with an active norepinephrine infusion |
| Amount of vasopressor used | during surgery | Amount of vasopressor administered to the patient |
| Incidence of acute kidney injury | 30 days postsurgery | Incidence of acute kidney injury defined with the KDIGO classification |
Countries
Belgium
Outcome results
None listed