Hemodynamic MAP StabilityNCT04232007
Closed-loop Control of Vasopressor Administration in Cardiac Surgery
A study testing closed-loop system for vasopressor administration 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 for vasopressor administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 16 May 2018to 30 Aug 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 cardiac surgery (robotic, off-pump and on pump cardiac surgery)
Who cannot join
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed-loop Control of Vasopressor Administration in High-Risk Patients Undergoing Cardiac Surgery: A Case Series
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 in three high risk patients undergoing cardiac surgery
Read the detailed description
The investigators have recently developed an automated closed-loop vasopressor (CLV) controller to better titrate vasopressor (e.g:norepinephrine) to maintain MAP within a narrow range (±5mmHg of the chosen target).
The investigators published engineering, animal studies and recently described the feasibility of titration of norepinephrine in 20 patients undergoing major noncardiac procedures. This initial cohort human study showed the controller was able to keep patients within ± 5 mmHg of a target pressure for more than 90% of management time. Cardiac surgery represents unique challenges in MAP management as the manipulation of the heart itself, the use of cardiopulmonary bypass (CPB) and cardioplegia, and the pre-existing cardiac disease all increase the difficulty in maintaining a steady MAP throughout the surgical period.
In this case series the investigators describe three cardiac surgical procedures managed with the CLV system (one coronary artery bypass graft (CABG) procedure done under CPB; one robotic minimally invasive direct coronary artery bypass (MIDCAB) procedure (through a mini-thoracotomy), and one off-pump CABG) in order to assess its feasibility, efficiency and behavior in three high-risk patients before starting a randomized controlled trial.
- Conditions
- Hemodynamic MAP Stability
- Being tested
- closed-loop system for vasopressor administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop system for vasopressor administrationDevice
closed-loop system for vasopressor administration
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop | Experimental | Closed-loop system to titrate vasopressor during surgery Receives: Device: closed-loop system for vasopressor administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time spent during surgery in hypotension
percentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.
Measured: during surgery
Secondary outcomes (3)
time in target during surgery
time with a MAP within 5 mmHg of the chosen target
Measured: during surgery
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start16 May 2018
- Primary completion14 Aug 2018
- Study completion30 Aug 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Closed-loop system to titrate vasopressor
- 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 Joosten, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232007
- Sponsor's protocol ID
- P2018(276)
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 18 Jan 2020
- 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 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Control of Vasopressor Administration in High-Risk Patients Undergoing Cardiac Surgery: A Case Series
- ClinicalTrials.gov ID
- NCT04232007
- 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
- 16 May 2018 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 18 Jan 2020 (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 in three high risk patients undergoing cardiac surgery
Detailed description
The investigators have recently developed an automated closed-loop vasopressor (CLV) controller to better titrate vasopressor (e.g:norepinephrine) to maintain MAP within a narrow range (±5mmHg of the chosen target).
The investigators published engineering, animal studies and recently described the feasibility of titration of norepinephrine in 20 patients undergoing major noncardiac procedures. This initial cohort human study showed the controller was able to keep patients within ± 5 mmHg of a target pressure for more than 90% of management time. Cardiac surgery represents unique challenges in MAP management as the manipulation of the heart itself, the use of cardiopulmonary bypass (CPB) and cardioplegia, and the pre-existing cardiac disease all increase the difficulty in maintaining a steady MAP throughout the surgical period.
In this case series the investigators describe three cardiac surgical procedures managed with the CLV system (one coronary artery bypass graft (CABG) procedure done under CPB; one robotic minimally invasive direct coronary artery bypass (MIDCAB) procedure (through a mini-thoracotomy), and one off-pump CABG) in order to assess its feasibility, efficiency and behavior in three high-risk patients before starting a randomized controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Closed-loop system to titrate vasopressor
| Arm | Type | Receives |
|---|---|---|
| Closed-loop | Experimental | Device: closed-loop system for vasopressor administrationClosed-loop system to titrate vasopressor during surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult high risk patients undergoing cardiac surgery (robotic, off-pump and on pump cardiac surgery)
Key exclusion criteria (1 listed)
- Atrial fibrillation
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 system for vasopressor administrationclosed-loop system for vasopressor administration | Device | Closed-loop |
Primary outcome
percentage of time spent during surgery in hypotension
Time frame: during surgery
percentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.
3 secondary outcomes
time in target during surgery
Time frame: during surgery
Percentage of active treatment time spent in a hypertensive state
Time frame: during surgery
Amount of vasopressor used
Time frame: during surgery
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 Jan 2020.
- 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 Joosten 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 for vasopressor administration 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 1 inclusion and 1 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 Jan 2020. 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 time spent during surgery 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 Jan 2020.