Cardiovascular DiseasesNCT04357197
Closed-loop Control Mean Arterial Pressure In Intensive Care Patients
A study testing Closed-loop in people with Cardiovascular Diseases, run by Erasme University Hospital.
Trial summary
The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Closed-loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2020to 1 Jan 2021
- 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
- All patients in the intensive care unit (awake or under sedation)
- Requiring norepinephrine to maintain a MAP of 80 mmHg
- Equiped with an arterial line
Who cannot join
- Subjects under 18 years of age
- Subject with Atrial Fibrillation
- Subjects who are pregnant
About this study
Official title: Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Case Series
The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients
Read the detailed description
In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 72mmHg) during a two hours study protocol in critically ill patients.
The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP < 90% of MAP target ( 80 mmHg - 10% = 72 mmHg)
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol.
Participants will receive standard patient care
Fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h
- Conditions
- Cardiovascular Diseases
- Being tested
- Closed-loop
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loopDevice
The system will be tested to see if it can avoid hypotension
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop | Experimental | Closed-loop administration of norepinephrine in critically ill patients 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 <72 mmHg)
The primary outcome will be the percentage of case time in predefined MAP target
Measured: During thetwo hours study protocol
Secondary outcomes (2)
percentage of case time with MAP >88 mmHg with norepinephrine still running
overtreatment
Measured: During the two hours study protocol
Amount of vasopressors received
Amount of vasopressors received (norepinephrine)
Measured: During the two hours study protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start25 Sep 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: We did not want to start a case series as we already finished a RCT...SO this study is now outdated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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 single center study
- Masking
- None (open label)
- Enrolment
- 0 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, MD PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357197
- Sponsor's protocol ID
- P2020-157
- Status last verified
- Feb 2021
- First submitted
- 19 Apr 2020
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Case Series
- ClinicalTrials.gov ID
- NCT04357197
- Acronym / sponsor ID
- P2020-157
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not want to start a case series as we already finished a RCT...SO this study is now outdated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 22 Apr 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.
The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients
Detailed description
In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 72mmHg) during a two hours study protocol in critically ill patients.
The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP < 90% of MAP target ( 80 mmHg - 10% = 72 mmHg)
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol.
Participants will receive standard patient care
Fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single prospective single center study
| Arm | Type | Receives |
|---|---|---|
| Closed-loop | Experimental | Device: Closed-loopClosed-loop administration of norepinephrine in critically ill patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients in the intensive care unit (awake or under sedation)
- Requiring norepinephrine to maintain a MAP of 80 mmHg
- Equiped with an arterial line
Key exclusion criteria (3 listed)
- Subjects under 18 years of age
- 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-loopThe system will be tested to see if it can avoid hypotension | Device | Closed-loop |
Primary outcome
Percentage of case Time in hypotension (MAP <72 mmHg)
Time frame: During thetwo hours study protocol
The primary outcome will be the percentage of case time in predefined MAP target
2 secondary outcomes
percentage of case time with MAP >88 mmHg with norepinephrine still running
Time frame: During the two hours study protocol
Amount of vasopressors received
Time frame: During the two hours study protocol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- 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, MD PhD principal investigator
ERASME
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop in people with Cardiovascular Diseases, run by Erasme University Hospital.
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 3 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: withdrawn, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 <72 mmHg) (time frame: During thetwo hours study protocol). 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 23 Feb 2021.