Hemodynamic (MAP) StabilityNCT04111055
Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring
A study testing Closed-loop system in people with Hemodynamic (MAP) Stability, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemodynamic (MAP) Stability
- What is being tested?
- Closed-loop system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2018to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult high risk patients undergoing renal transplant surgery
- Patients equipped with a clearsight advanced hemodynamic monitoring system
Who cannot join
- Atrial fibrillation
- No consent obtained from the patient.
- Ejection fraction < 30%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant Surgery
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
Read the 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)
- Conditions
- Hemodynamic (MAP) Stability
- Being tested
- Closed-loop system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop systemDevice
the CLV system will correct hypotension by automated adjustment of norepinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop group | Experimental | The MAP of the patient will be managed by the CLV system to avoid hypotension. The MAP target selected in the closed-loop system will be the patient's MAP target ( same target as patient's MAP value preoperatively). Then the closed-loop system will have to adjust norepinephrine infusion rate to keep that MAP value within 10% of patient's target. Receives: Device: Closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of case time in hypotension
% of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target
Measured: during surgery
Secondary outcomes (3)
Percentage of active treatment time spent in a hypertensive state
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
Measured: during surgery
Amount of vasopressor used
Amount of vasopressor administered to the patient
Measured: during surgery
Incidence of acute kidney injury
Incidence of acute kidney injury defined with the KDIGO classification
Measured: 30 days postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Jun 2018
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic (MAP) StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single prospective pilot study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Alexandre J Joosten, MD PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111055
- Sponsor's protocol ID
- P2018-276
- Status last verified
- Nov 2019
- First submitted
- 29 Sep 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant Surgery
- ClinicalTrials.gov ID
- NCT04111055
- Acronym / sponsor ID
- P2018-276
- Conditions
- Hemodynamic (MAP) Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, Irvine
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Closed-loop group | Experimental | Device: Closed-loop systemThe MAP of the patient will be managed by the CLV system to avoid hypotension. The MAP target selected in the closed-loop system will be the patient's MAP target ( same target as patient's MAP value preoperatively). Then the closed-loop system will have to adjust norepinephrine infusion rate to keep that MAP value within 10% of patient's target. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult high risk patients undergoing renal transplant surgery
- Patients equipped with a clearsight advanced hemodynamic monitoring system
Key exclusion criteria (3 listed)
- Atrial fibrillation
- No consent obtained from the patient.
- Ejection fraction < 30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop systemthe CLV system will correct hypotension by automated adjustment of norepinephrine. | Device | Closed-loop group |
Primary outcome
Percentage of case time in hypotension
Time frame: during surgery
% of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target
3 secondary outcomes
Percentage of active treatment time spent in a hypertensive state
Time frame: during surgery
Amount of vasopressor used
Time frame: during surgery
Incidence of acute kidney injury
Time frame: 30 days postsurgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre J Joosten, MD PhD principal investigator
ERASME
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop system in people with Hemodynamic (MAP) Stability, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of case time in hypotension (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.