Closed-Loop CommunicationCLVNCT03515161
Closed-Loop Titration of Vasopressor Infusions: Feasibility Study or Proof of Concept Study
A study testing closed-loop in people with Closed-Loop Communication and Hemodynamic Instability, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac or Clearsight system, Edwards Lifesciences, IRVINE, USA). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Closed-Loop Communication, Hemodynamic Instability
- What is being tested?
- closed-loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2018to 27 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over the age of 18
- Subjects undergoing elective high risk surgery (either vascular-cardiac- or transplant)
- Subjects requiring general anesthesia and mechanical ventilation
- Subjects requiring cardiac output monitoring with an arterial line
Who cannot join
- Subjects under 18 years of age
- Subjects not undergoing surgery
- Subjects not requiring general anesthesia or mechanical ventilation
- Subjects not requiring cardiac output monitoring or an arterial line
- Subject with Atrial Fibrillation
- Subjects who are pregnant
- Subjects without the capacity to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-assisted Vasopressor Infusion for Hemodynamic Optimization in Patients Undergoing High Risk Surgery
The purpose of this study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac or Clearsight system, Edwards Lifesciences, IRVINE, USA).
Read the detailed description
In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 65mmHg). The target MAP will be set at 70mmHg, except for neuro embolisation case where MAP can be higher. The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The Investigators have shown this to be the case in simulation studies and in-vivo animal studies (under submission) but not yet experimentally in a clinical setting. Investigators will recruit their patients from the surgical record that that require a mini-invasive or a non-invasive cardiac output monitoring (EV1000 monitoring using the Flotrac or clearsight system) ; either high risk patients undergoing high risk surgery (vascular-cardiac- Major Abdominal or renal transplant, neuro-endo-vascular surgery (aneuvrysm) and require mechanical ventilation and consent to participate in the study will be included in the study.
The investigators will also test the system in a short series of patients in the ICU setting ( critically ill patients): ideally in 3-4 "types" of patients ( septic patients, neuro ICU patients, ARDS patients and postoperative patients( ideally intubated patients or sedated patients) .The target mean arterial pressure can be different from the 70 mmHg of the surgical patients especially for the neurologic patients (head trauma injury patients or neuro-endovascular surgical patients). In these two subgroups of patients, the target MAP can even vary during the case depending on the surgeons requests (neuro radiologists) or depending on cerebral autoregulation.
Participants 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 given as goal directed therapy using the assisted fluid management software present in the EV1000 monitor (only for vascular and abdominal cases).
The closed loop (automated) system will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of vasopressor infusion rate the patient receives using feedback from standard operating room monitors at ERASME HOSPITAL Data from this study will also be retrospectively compared to subjects case matched to evaluate differences in MAP time in target, total amount of vasopressor received, and patient outcomes (for patients undergoing high risk surgery and/or neuro endovascular patients)
- Conditions
- Closed-Loop Communication, Hemodynamic Instability
- Being tested
- closed-loop
- Keywords
- closedloop, vasopressor
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loopDevice
Vasopressor admnistration in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of vasopressor the patient receives using feedback from standard operating room monitors.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop | Experimental | Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed manually using the assisted fluid management sofware from the EV1000 monitor. A closed-loop system will automatically administer vasopressor based on the predefined target MAP chosen by the anesthesiologist in charge of the patient Receives: Device: closed-loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of case Time in hypotension (MAP <65 mmHg) for surgical patients. For potential recrutment of critically ill patients in the ICU, this target can be different (higher, depending on the type of patient and comorbidities)
The primary outcome will be the percentage of case time in predefined MAP target
Measured: At postoperative day 1
Secondary outcomes (2)
percentage of case time with MAP >75 mmHg with norepinephrine still running
overtreatment
Measured: At postoperative day 1
Amount of vasopressors received
Amount of vasopressors received
Measured: At postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start26 Apr 2018
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Closed-Loop CommunicationStudies 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 GROUP ASSIGNMENT
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Joosten, Erasme University Hospital
- Investigators
- Alexandre Joosten, M.D, Principal investigator, Erasme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515161
- Sponsor's protocol ID
- P2018/276
- Acronym
- CLV
- Status last verified
- Sep 2018
- First submitted
- 17 Apr 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can provide individual patients data ( all hemodynamic data)
Publications
Joosten A, Alexander B, Duranteau J, Taccone FS, Creteur J, Vincent JL, Cannesson M, Rinehart J. Feasibility of closed-loop titration of norepinephrine infusion in patients undergoing moderate- and high-risk surgery. Br J Anaesth. 2019 Oct;123(4):430-438. doi: 10.1016/j.bja.2019.04.064. Epub 2019 Jun 27.
PubMed 31255290
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Vasopressor Infusion for Hemodynamic Optimization in Patients Undergoing High Risk Surgery
- ClinicalTrials.gov ID
- NCT03515161
- Acronym / sponsor ID
- CLV / P2018/276
- Conditions
- Closed-Loop Communication, Hemodynamic Instability
- Keywords
- closedloop, vasopressor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 3 May 2018 (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.
The purpose of this study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac or Clearsight system, Edwards Lifesciences, IRVINE, USA).
Detailed description
In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 65mmHg). The target MAP will be set at 70mmHg, except for neuro embolisation case where MAP can be higher. The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The Investigators have shown this to be the case in simulation studies and in-vivo animal studies (under submission) but not yet experimentally in a clinical setting. Investigators will recruit their patients from the surgical record that that require a mini-invasive or a non-invasive cardiac output monitoring (EV1000 monitoring using the Flotrac or clearsight system) ; either high risk patients undergoing high risk surgery (vascular-cardiac- Major Abdominal or renal transplant, neuro-endo-vascular surgery (aneuvrysm) and require mechanical ventilation and consent to participate in the study will be included in the study.
The investigators will also test the system in a short series of patients in the ICU setting ( critically ill patients): ideally in 3-4 "types" of patients ( septic patients, neuro ICU patients, ARDS patients and postoperative patients( ideally intubated patients or sedated patients) .The target mean arterial pressure can be different from the 70 mmHg of the surgical patients especially for the neurologic patients (head trauma injury patients or neuro-endovascular surgical patients). In these two subgroups of patients, the target MAP can even vary during the case depending on the surgeons requests (neuro radiologists) or depending on cerebral autoregulation.
Participants 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 given as goal directed therapy using the assisted fluid management software present in the EV1000 monitor (only for vascular and abdominal cases).
The closed loop (automated) system will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of vasopressor infusion rate the patient receives using feedback from standard operating room monitors at ERASME HOSPITAL Data from this study will also be retrospectively compared to subjects case matched to evaluate differences in MAP time in target, total amount of vasopressor received, and patient outcomes (for patients undergoing high risk surgery and/or neuro endovascular patients)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SINGLE GROUP ASSIGNMENT
| Arm | Type | Receives |
|---|---|---|
| Closed-loop | Experimental | Device: closed-loopStudy patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed manually using the assisted fluid management sofware from the EV1000 monitor. A closed-loop system will automatically administer vasopressor based on the predefined target MAP chosen by the anesthesiologist in charge of the patient |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects over the age of 18
- Subjects undergoing elective high risk surgery (either vascular-cardiac- or transplant)
- Subjects requiring general anesthesia and mechanical ventilation
- Subjects requiring cardiac output monitoring with an arterial line
Key exclusion criteria (7 listed)
- Subjects under 18 years of age
- Subjects not undergoing surgery
- Subjects not requiring general anesthesia or mechanical ventilation
- Subjects not requiring cardiac output monitoring or an arterial line
- Subject with 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-loopVasopressor admnistration in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of vasopressor the patient receives using feedback from standard operating room monitors. | Device | Closed-loop |
Primary outcome
Percentage of case Time in hypotension (MAP <65 mmHg) for surgical patients. For potential recrutment of critically ill patients in the ICU, this target can be different (higher, depending on the type of patient and comorbidities)
Time frame: At postoperative day 1
The primary outcome will be the percentage of case time in predefined MAP target
2 secondary outcomes
percentage of case time with MAP >75 mmHg with norepinephrine still running
Time frame: At postoperative day 1
Amount of vasopressors received
Time frame: At postoperative day 1
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 14 Sep 2018.
- Derived from this study: PubMed 31255290Joosten A, Alexander B, Duranteau J, Taccone FS, Creteur J, Vincent JL, Cannesson M, Rinehart J. Feasibility of closed-loop titration of norepinephrine infusion in patients undergoing moderate- and high-risk surgery. Br J Anaesth. 2019 Oct;123(4):430-438. doi: 10.1016/j.bja.2019.04.064. Epub 2019 Jun 27.
- Individual participant dataSharing planned: Yes. We can provide individual patients data ( all hemodynamic data)
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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, M.D 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 in people with Closed-Loop Communication and Hemodynamic Instability, 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 4 inclusion and 7 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 14 Sep 2018. 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 (MAP <65 mmHg) for surgical patients. For potential recrutment of critically ill patients in the ICU, this target can be different (higher, depending on the type of patient and comorbidities) (time frame: At postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515161, which also lists 1 linked publication.
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 14 Sep 2018.