Cardiac DiseaseATRAP-GCSNCT04620694
Impact of Arterial Cannulation Site on Vasopressor Requirement in Cardiac Surgery
An observational study of Cardiac Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Choice of arterial cannulation site at the beginning of the surgery
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to Feb 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass
Who may be able to join
- Adult patient
- Scheduled for cardiac surgery with cardiopulmonary bypass
Who cannot join
- More than one arterial cannula at the beginning of the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Arterial Cannulation Site on Vasopressor Requirement During Cardiac Surgery: a Monocentric Prospective Cohort Study
Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.
- Conditions
- Cardiac Disease
- Being tested
- Choice of arterial cannulation site at the beginning of the surgery
- Keywords
- Cardiac surgery, Aortic to radial arterial pressure gradient, Vasopressor
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of arterial cannulation site at the beginning of the surgeryDevice
Choice of arterial cannulation site at the beginning of the surgery is at the discretion of the anesthesia physician.
| Study group | Role | What they receive |
|---|---|---|
| Radial artery cannulation | Patients whom radial artery was cannulated at the beginning of the surgery. | |
| Aortic cannulation (brachial or femoral artery) | Patients whom femoral or brachial artery was cannulated at the beginning of the surgery.
Active comparator Receives: Device: Choice of arterial cannulation site at the beginning of the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative vasopressor requirement
Mean intraoperative dosage of Norepinephrine (µg.kg-1.min-1)
Measured: end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Oct 2020
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620694
- Sponsor's protocol ID
- 69HCL20_0947
- Acronym
- ATRAP-GCS
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Arterial Cannulation Site on Vasopressor Requirement During Cardiac Surgery: a Monocentric Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04620694
- Acronym / sponsor ID
- ATRAP-GCS / 69HCL20_0947
- Conditions
- Cardiac Disease
- Keywords
- Cardiac surgery, Aortic to radial arterial pressure gradient, Vasopressor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 9 Nov 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.
Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial artery cannulation | – | –Patients whom radial artery was cannulated at the beginning of the surgery. |
| Aortic cannulation (brachial or femoral artery) | – | Device: Choice of arterial cannulation site at the beginning of the surgeryPatients whom femoral or brachial artery was cannulated at the beginning of the surgery. Active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass
Key inclusion criteria (2 listed)
- Adult patient
- Scheduled for cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (1 listed)
- More than one arterial cannula at the beginning of the surgery
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 |
|---|---|---|
| Choice of arterial cannulation site at the beginning of the surgeryChoice of arterial cannulation site at the beginning of the surgery is at the discretion of the anesthesia physician. | Device | Aortic cannulation (brachial or femoral artery) |
Primary outcome
Intraoperative vasopressor requirement
Time frame: end of surgery
Mean intraoperative dosage of Norepinephrine (µg.kg-1.min-1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Hospices Civils de Lyon at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Nov 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Remi Schweizer, MD (0033472318933, remi.schweizer@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative vasopressor requirement (time frame: end of 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 9 Nov 2020.