Acute Respiratory Distress SyndromeIMPECNCT03262155
Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)
An observational study of Acute Respiratory Distress Syndrome and Cardiogenic Shock, run by Rennes University Hospital at 1 site in France.
Trial summary
Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Cardiogenic Shock
- What is being tested?
- Blood test
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 31 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for ARDS or Cardiogenic shock with or without ECMO / ECLS
Who may be able to join
- Patient older than 18 years old
- Patient hospitalized in an intensive care unit
- Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission
- Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS
Who cannot join
- Opposition of patient, relative or legal representative for participation in the study
- Pregnant woman
- Pre-immunodepression
- Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (> 0.5mg / kg / day).
Trial locations and contacts
1 site in 1 country.
About this study
Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS
- Being tested
- Blood test
- Medical subject headings
- Respiratory Distress Syndrome, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
| Study group | Role | What they receive |
|---|---|---|
| ECMO / ECLS | Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS Receives: Biological: Blood test | |
| No ECMO / ECLS | Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Jan 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262155
- Sponsor's protocol ID
- 35RC16_3037_IMPECstudy
- Acronym
- IMPEC
- Status last verified
- Apr 2023
- First submitted
- 23 Aug 2017
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)
- ClinicalTrials.gov ID
- NCT03262155
- Acronym / sponsor ID
- IMPEC / 35RC16_3037_IMPECstudy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 25 Aug 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.
Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO / ECLS | – | Biological: Blood testPatients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS |
| No ECMO / ECLS | – | Biological: Blood testPatients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for ARDS or Cardiogenic shock with or without ECMO / ECLS
Key inclusion criteria (4 listed)
- Patient older than 18 years old
- Patient hospitalized in an intensive care unit
- Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission
- Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS
Key exclusion criteria (4 listed)
- Opposition of patient, relative or legal representative for participation in the study
- Pregnant woman
- Pre-immunodepression
- Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (> 0.5mg / kg / day).
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 test | Biological | ECMO / ECLS, No ECMO / ECLS |
Primary outcome
Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit
Time frame: Hour 24
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 12 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Respiratory Distress Syndrome and Cardiogenic Shock, run by Rennes 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 4 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 12 Apr 2023. 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?
Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit (time frame: Hour 24). 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 12 Apr 2023.