Cardiovascular DiseasesNCT04357301
Tight Closed-loop Systolic Arterial Pressure Control
A study testing Closed-loop vasopressor in people with Cardiovascular Diseases, run by Erasme University Hospital at 1 site in Belgium.
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 operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA). 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 vasopressor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2020to 30 Oct 2020
- 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 patients (age of >17)
- Elective high-risk abdominal surgery
- Patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation < 13%)
Who cannot join
- Atrial Fibrillation
- Pregnancy
- Subjects without the capacity to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tight Systolic Arterial Pressure Control Using a Closed-loop System for Vasopressor Infusion in Patients Undergoing High-risk Abdominal Surgery: A Proof-of-Concept Study
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 operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA).
Read the detailed description
In this case series, the investigators will report the percentage of case time in hypotension (defined as systolic arterial pressure (SAP) < 117mmHg). The target mean arterial pressure (MAP) will be set at a SAP of 130mmHg in all patients. Definition of Hypotension is target SAP - 10% (130mmHg - 13 mmHg = 117 mmHg). We will use the same SAP target in all patients even if we used a modified definition of hypotension from the study of Futier and colleagues ( JAMA 2017). We won't use a individualized SAP for each patient but the same SAP target in all patients.
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The Investigators have shown the system works well based on a target MAP but not yet using a target of SAP.
The investigators will test the system in a pilot study of 13 patients undergoing High-risk abdominal surgery which require the placement of a arterial catheter, the optimization of fluid therapy and a tight SAP control.
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 ( automatically delivery instead of manually adjustments)
Fluids will be given as goal directed fluid therapy in order to maintain stroke volume variation below 13% (hospital guidelines).
- Conditions
- Cardiovascular Diseases
- Being tested
- Closed-loop vasopressor
- 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-loop vasopressorDevice
The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop | Experimental | Closed-loop administration of norepinephrine Receives: Device: Closed-loop vasopressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of case Time in hypotension (SAP <117 mmHg)
The primary outcome will be the percentage of case time in predefined SAP target (SAP of 130 mmHg -10 % = 117 mmHg)
Measured: At postoperative day 1
Secondary outcomes (3)
Amount of vasopressors received
Amount of vasopressors received (norepinephrine)
Measured: At postoperative day 1
Number of vasopressors infusion rate modifications
Number of vasopressors infusion rate modifications
Measured: At postoperative day 1
Percentage of case time with a MAP < 65 mmHg
Percentage of case time with a MAP < 65 mmHg
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 posted22 Apr 2020
- Study start25 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
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 pilot study (12 patients)
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04357301
- Sponsor's protocol ID
- P2020/157
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2020
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Systolic Arterial Pressure Control Using a Closed-loop System for Vasopressor Infusion in Patients Undergoing High-risk Abdominal Surgery: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT04357301
- Acronym / sponsor ID
- P2020/157
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- 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 operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA).
Detailed description
In this case series, the investigators will report the percentage of case time in hypotension (defined as systolic arterial pressure (SAP) < 117mmHg). The target mean arterial pressure (MAP) will be set at a SAP of 130mmHg in all patients. Definition of Hypotension is target SAP - 10% (130mmHg - 13 mmHg = 117 mmHg). We will use the same SAP target in all patients even if we used a modified definition of hypotension from the study of Futier and colleagues ( JAMA 2017). We won't use a individualized SAP for each patient but the same SAP target in all patients.
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The Investigators have shown the system works well based on a target MAP but not yet using a target of SAP.
The investigators will test the system in a pilot study of 13 patients undergoing High-risk abdominal surgery which require the placement of a arterial catheter, the optimization of fluid therapy and a tight SAP control.
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 ( automatically delivery instead of manually adjustments)
Fluids will be given as goal directed fluid therapy in order to maintain stroke volume variation below 13% (hospital guidelines).
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 (12 patients)
| Arm | Type | Receives |
|---|---|---|
| Closed-loop | Experimental | Device: Closed-loop vasopressorClosed-loop administration of norepinephrine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age of >17)
- Elective high-risk abdominal surgery
- Patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation < 13%)
Key exclusion criteria (3 listed)
- Atrial Fibrillation
- Pregnancy
- Subjects without the capacity to give informed consent
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 vasopressorThe system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients | Device | Closed-loop |
Primary outcome
Percentage of case Time in hypotension (SAP <117 mmHg)
Time frame: At postoperative day 1
The primary outcome will be the percentage of case time in predefined SAP target (SAP of 130 mmHg -10 % = 117 mmHg)
3 secondary outcomes
Amount of vasopressors received
Time frame: At postoperative day 1
Number of vasopressors infusion rate modifications
Time frame: At postoperative day 1
Percentage of case time with a MAP < 65 mmHg
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 15 Mar 2021.
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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
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 vasopressor in people with Cardiovascular Diseases, 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 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: finished, as of the sponsor's last update on 15 Mar 2021. 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 (SAP <117 mmHg) (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?
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 15 Mar 2021.