Respiratory FailureNCT02542423
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
A study testing Endocan blood test samples in people with Respiratory Failure and Postoperative Complications, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Postoperative Complications
- What is being tested?
- Endocan blood test samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give written consent
- Elective cardiac surgery
- More than 18 years old
Who cannot join
- Less than 18 years old
- urgency / emergency cardiac surgery
- pregnancy
- refusal
- unable to give written consent
- oncologic patients
- concomitant inflammatory or infective pulmonary disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. The ENDOLUNG Study
According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients.
Read the detailed description
Endocan is an endothelium derived soluble dermatan sulfate proteoglycan. Literature data shows that alterate levels of its blood concentration correlate with the onset of pulmonary failure in patients with major trauma and septic shock.
In cardiac surgery respiratory failure and infections are threatening complications leading to mortality rates up to 80%. A rapid diagnosis and treatment of this pathology is crucial to improve the clinical outcome.
Unfortunately specific data for the efficacy of Endocan predictive value in cardiac surgery patients are not available.
The investigators aim to determinate if Endocan can be a helpful tool to identify patients developing acute respiratory failure after cardiac surgery and anticipate specific treatment in order to improve survival.
- Conditions
- Respiratory Failure, Postoperative Complications
- Being tested
- Endocan blood test samples
- Medical subject headings
- Respiratory Insufficiency, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocan blood test samplesOther
Also called Endocan, Endolung
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing cardiac surgery | Other | Not described Receives: Other: Endocan blood test samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Endocan blood levels after cardiac surgery and its correlation with postoperative pulmonary failure
The investigators will enroll 150 patients undergoing elective cardiac surgery. Every participant will be prelevated of several blood samples following this time frame : day -1 from intervention, day 0 ( six hours after intervention), day 1 , day 2 , day 3. All patients will be observed to detect all infections, especially pulmonary ones, up to hospital discharge. Endocan blood levels of patients developing pulmonary failure and patients without postoperative respiratory insufficiency will be compared.
Measured: from day -1 of the intervention to day 3, one blood sample per day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea PERROTTI, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542423
- Sponsor's protocol ID
- CPP 15/479
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chazal E, Morin L, Chocron S, Lassalle P, Pili-Floury S, Salomon du Mont L, Ferreira D, Samain E, Perrotti A, Besch G. Impact of early postoperative blood glucose variability on serum endocan level in cardiac surgery patients: a sub study of the ENDOLUNG observational study. Cardiovasc Diabetol. 2023 Aug 24;22(1):221. doi: 10.1186/s12933-023-01959-5.
PubMed 37620974
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. The ENDOLUNG Study
- ClinicalTrials.gov ID
- NCT02542423
- Acronym / sponsor ID
- CPP 15/479
- Conditions
- Respiratory Failure, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- 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.
According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients.
Detailed description
Endocan is an endothelium derived soluble dermatan sulfate proteoglycan. Literature data shows that alterate levels of its blood concentration correlate with the onset of pulmonary failure in patients with major trauma and septic shock.
In cardiac surgery respiratory failure and infections are threatening complications leading to mortality rates up to 80%. A rapid diagnosis and treatment of this pathology is crucial to improve the clinical outcome.
Unfortunately specific data for the efficacy of Endocan predictive value in cardiac surgery patients are not available.
The investigators aim to determinate if Endocan can be a helpful tool to identify patients developing acute respiratory failure after cardiac surgery and anticipate specific treatment in order to improve survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing cardiac surgery | Other | Other: Endocan blood test samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give written consent
- Elective cardiac surgery
- More than 18 years old
Key exclusion criteria (7 listed)
- Less than 18 years old
- urgency / emergency cardiac surgery
- pregnancy
- refusal
- unable to give written 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 |
|---|---|---|
| Endocan blood test samplesAlso: Endocan, Endolung | Other | patients undergoing cardiac surgery |
Primary outcome
Changes of Endocan blood levels after cardiac surgery and its correlation with postoperative pulmonary failure
Time frame: from day -1 of the intervention to day 3, one blood sample per day
The investigators will enroll 150 patients undergoing elective cardiac surgery. Every participant will be prelevated of several blood samples following this time frame : day -1 from intervention, day 0 ( six hours after intervention), day 1 , day 2 , day 3. All patients will be observed to detect all infections, especially pulmonary ones, up to hospital discharge. Endocan blood levels of patients developing pulmonary failure and patients without postoperative respiratory insufficiency will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Derived from this study: PubMed 37620974Chazal E, Morin L, Chocron S, Lassalle P, Pili-Floury S, Salomon du Mont L, Ferreira D, Samain E, Perrotti A, Besch G. Impact of early postoperative blood glucose variability on serum endocan level in cardiac surgery patients: a sub study of the ENDOLUNG observational study. Cardiovasc Diabetol. 2023 Aug 24;22(1):221. doi: 10.1186/s12933-023-01959-5.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endocan blood test samples in people with Respiratory Failure and Postoperative Complications, run by Centre Hospitalier Universitaire de Besancon.
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 7 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 7 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sidney Chocron, MD Ph D (+33381668662, sidney.chocron@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Endocan blood levels after cardiac surgery and its correlation with postoperative pulmonary failure (time frame: from day -1 of the intervention to day 3, one blood sample per day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542423, which also lists 1 linked publication.
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 7 Sep 2015.