Closed-Loop CommunicationNCT04106791
Computer Assisted Vasopressor Titration in Critically Ill Patients
A study testing closed-loop system for vasopressor administration in people with Closed-Loop Communication, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The purpose of this pilot 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 Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Closed-Loop Communication
- 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
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2018to 30 Oct 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
- ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device
Who cannot join
- Subjects under 18 years of age
- Subjects not requiring cardiac output monitoring or an arterial line
- Subject with Atrial Fibrillation
- Subjects who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
The purpose of this pilot 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 Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.
Read the detailed description
The investigators have developed an automated closed-loop system for vasopressor administration . They will test it in critically ill patients. The investigators want to demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the treatment time.
The Investigators have shown this to be the case in simulation studies and in-vivo animal studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring and under continuous norepinephrine infusion.
These patients will typically include: septic patients, neuro ICU patients, ARDS patients, trauma patients or postoperative patients.
The target MAP will be determined by the ICU physician in charge of the patient.
Fluids will be given standard of care. The closed loop (automated) system will use an infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor (norepinephrine)
The goal is to register a period of two hours of closed-loop control of MAP.
- Conditions
- Closed-Loop Communication
- Being tested
- closed-loop system for vasopressor administration
- 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-loop system for vasopressor administrationDevice
The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop | Experimental | Pilot study: one single group of 10 ICU patients. 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 case Time in target (MAP within 5 mmHg of the predetermined MAP target).
The primary outcome will be the percentage of case time in target
Measured: 48 hours post-admission in the intensive care
Secondary outcomes (5)
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Measured: 48 hours post-admission in the intensive care
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Measured: 48 hours post-admission in the intensive care
Amount of vasopressors received
Amount of vasopressors received
Measured: 48 hours post-admission in the intensive care
Number of vasopressor modifications over the treatment time
Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time
Measured: 48 hours post-admission in the intensive care
Limitations of the closed-loop system
Number of errors, malfunction of the system during the treatment time
Measured: 48 hours post-admission in the intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start26 Apr 2018
- Primary completion30 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SINGLE GROUP ASSIGNMENT
- Masking
- None (open label)
- Enrolment
- 10 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 MD, PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106791
- Sponsor's protocol ID
- P2018276
- Status last verified
- Nov 2019
- First submitted
- 25 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
- Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04106791
- Acronym / sponsor ID
- P2018276
- Conditions
- Closed-Loop Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 27 Sep 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.
The purpose of this pilot 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 Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.
Detailed description
The investigators have developed an automated closed-loop system for vasopressor administration . They will test it in critically ill patients. The investigators want to demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the treatment time.
The Investigators have shown this to be the case in simulation studies and in-vivo animal studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring and under continuous norepinephrine infusion.
These patients will typically include: septic patients, neuro ICU patients, ARDS patients, trauma patients or postoperative patients.
The target MAP will be determined by the ICU physician in charge of the patient.
Fluids will be given standard of care. The closed loop (automated) system will use an infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor (norepinephrine)
The goal is to register a period of two hours of closed-loop control of MAP.
Study design
- Primary purpose
- Device feasibility
- 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-loop system for vasopressor administrationPilot study: one single group of 10 ICU patients. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device
Key exclusion criteria (4 listed)
- Subjects under 18 years of age
- Subjects not requiring cardiac output monitoring or an arterial line
- Subject with Atrial Fibrillation
- Subjects who are pregnant
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 administrationThe closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP. | Device | Closed-loop |
Primary outcome
Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target).
Time frame: 48 hours post-admission in the intensive care
The primary outcome will be the percentage of case time in target
5 secondary outcomes
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Time frame: 48 hours post-admission in the intensive care
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Time frame: 48 hours post-admission in the intensive care
Amount of vasopressors received
Time frame: 48 hours post-admission in the intensive care
Number of vasopressor modifications over the treatment time
Time frame: 48 hours post-admission in the intensive care
Limitations of the closed-loop system
Time frame: 48 hours post-admission in the intensive care
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 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 for vasopressor administration in people with Closed-Loop Communication, 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 4 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 target (MAP within 5 mmHg of the predetermined MAP target). (time frame: 48 hours post-admission in the intensive care). 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.