Cardiac SurgeryIMMUNOPEDNCT03309839
HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass
An observational study of Cardiac Surgery, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss. We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Blood collection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2018to 13 Apr 2019
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged ≤ 28 days after cardiac surgery under cardiopulmonary bypass
Who may be able to join
- Patients aged ≤ 28 days
- Admission after cardiac surgery under cardiopulmonary bypass
Who cannot join
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss.
We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass
- Conditions
- Cardiac Surgery
- Being tested
- Blood collection
- Keywords
- HLA-DR expression, cardiopulmonary bypass, neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
A sample of an additional blood tube will be taken in parallel with the blood test carried out for the treatment.
| Study group | Role | What they receive |
|---|---|---|
| neonates with cardiac surgery under cardiopulmonary bypass | Not described Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
HLA-DR expression
Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences) Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences)
Measured: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
Secondary outcomes (1)
Cytokines measurements
Pro and anti-inflammatory cytokine concentrations in the plasma measured by multiplex immunoassay
Measured: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start29 Jan 2018
- Primary completion14 Mar 2019
- Study completion13 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Alexis Chenouard, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309839
- Sponsor's protocol ID
- RC17_0359
- Acronym
- IMMUNOPED
- Status last verified
- Sep 2021
- First submitted
- 10 Oct 2017
- Last updated
- 24 Sep 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 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03309839
- Acronym / sponsor ID
- IMMUNOPED / RC17_0359
- Conditions
- Cardiac Surgery
- Keywords
- HLA-DR expression, cardiopulmonary bypass, neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 13 Apr 2019 (actual)
- First posted
- 16 Oct 2017 (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 determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss.
We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neonates with cardiac surgery under cardiopulmonary bypass | – | Other: Blood collection |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged ≤ 28 days after cardiac surgery under cardiopulmonary bypass
Key inclusion criteria (2 listed)
- Patients aged ≤ 28 days
- Admission after cardiac surgery under cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Lack of parental 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 |
|---|---|---|
| Blood collectionA sample of an additional blood tube will be taken in parallel with the blood test carried out for the treatment. | Other | neonates with cardiac surgery under cardiopulmonary bypass |
Primary outcome
HLA-DR expression
Time frame: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences) Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences)
1 secondary outcome
Cytokines measurements
Time frame: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
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 24 Sep 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.
Alexis Chenouard, Dr principal investigator
Nantes University Hospital
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 Surgery, run by Nantes University Hospital 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: finished, as of the sponsor's last update on 24 Sep 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 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?
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?
HLA-DR expression (time frame: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass). 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 24 Sep 2021.