Cardiac SurgeryENDOPULMNCT04616820
Endocan Blood Level in Pulmonary Circulation
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Endocan is a proteoglycan produced by the vascular endothelium. Animal studies suggested that the synthesis mainly happen in the pulmonary circulation, but this hypothesis has never been confirmed in humans. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, Lung
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients who are sheduled for on-pump coronary artery bypass surgery in the Cardiac Surgery Department of the University Hospital of Besancon.
Who may be able to join
- Planned on pump coronary artery bypass surgery
- Non opposition
Who cannot join
- Age < 18 years old
- Emergent surgery
- Valvular replacement surgery
- Combined cardiac surgery
- Patients with inflammatory, infectious or evolutive neoplastic pulmonary disease
- Patients with valvular problems, in particular aortic insufficiency
Show all 12Show fewer
- Patients who refuse to participate
- Legal inability or disability
- Patients who will probably not cooperate for the study
- Pregnancy and/or breast feeding
- Patients not in the Social security system
- Patients in the exclusion period of another study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery
Endocan is a proteoglycan produced by the vascular endothelium. Animal studies suggested that the synthesis mainly happen in the pulmonary circulation, but this hypothesis has never been confirmed in humans.
Read the detailed description
The investigators will measure endocan levels in both pulmonary and systemic venous blood in patients undergoing on pump cardiac surgery.
The main objective is to quantify the difference of endocan blood level between the pulmonary and the systemic circulation.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Lung
- Keywords
- Endocan
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the difference of Endocan blood levels between pulmonary and systemic circulation at the end of cardiopulmonary bypass
Blood samples will be collected at the same time in both pulmonary and systemic circulation at the end of cardiopulmonary bypass to measure Endocan blood level. The primary outcome will be the absolute difference between the Endocan blod level in the pulmonary circulation and in the systemic circulation.
Measured: At the end of cardiopulmonary bypass
Secondary outcomes (1)
Kinetic of Endocan blood level in the systemic circulation during on pump cardiac surgery
Blood samples will be collected in the systemic circulation prior to the start of cardiopulmonary bypass, at the beginning of the cardiopulmonary bypass and at the end of cardiopulmonary bypass, and at the end of the surgery
Measured: Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the 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 posted5 Nov 2020
- Study startMar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Biothelis
- Responsible party
- Sponsor
- Investigators
- Pascal DEBAT, Study chair, CHU Jean Minjoz Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616820
- Sponsor's protocol ID
- ENDOPULM
- Acronym
- ENDOPULM
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lassalle P, Molet S, Janin A, Heyden JV, Tavernier J, Fiers W, Devos R, Tonnel AB. ESM-1 is a novel human endothelial cell-specific molecule expressed in lung and regulated by cytokines. J Biol Chem. 1996 Aug 23;271(34):20458-64. doi: 10.1074/jbc.271.34.20458.
PubMed 8702785Kao SJ, Chuang CY, Tang CH, Lin CH, Bien MY, Yu MC, Bai KJ, Yang SF, Chien MH. Plasma endothelial cell-specific molecule-1 (ESM-1) in management of community-acquired pneumonia. Clin Chem Lab Med. 2014 Mar;52(3):445-51. doi: 10.1515/cclm-2013-0638.
PubMed 24108208Palud A, Parmentier-Decrucq E, Pastre J, De Freitas Caires N, Lassalle P, Mathieu D. Evaluation of endothelial biomarkers as predictors of organ failures in septic shock patients. Cytokine. 2015 Jun;73(2):213-8. doi: 10.1016/j.cyto.2015.02.013. Epub 2015 Mar 17.
PubMed 25794660Mikkelsen ME, Shah CV, Scherpereel A, Lanken PN, Lassalle P, Bellamy SL, Localio AR, Albelda SM, Meyer NJ, Christie JD. Lower serum endocan levels are associated with the development of acute lung injury after major trauma. J Crit Care. 2012 Oct;27(5):522.e11-7. doi: 10.1016/j.jcrc.2011.07.077. Epub 2011 Sep 29.
PubMed 21958978Mangat M, Amalakuhan B, Habib S, Reyes LF, Hinojosa CA, Rodriguez AH, Soni NJ, Anzueto A, Levine SM, Peters JI, Aliberti S, Sibila O, Rello J, Witzenrath M, Waterer GW, Martin-Loeches I, Blanquer J, Sanz F, Marcos PJ, Sole-Violan J, Chalmers JD, Feldman C, Wunderink RG, Cruz CSD, Orihuela CJ, Restrepo MI. High endocan levels are associated with the need for mechanical ventilation among patients with severe sepsis. Eur Respir J. 2017 Jul 5;50(1):1700013. doi: 10.1183/13993003.00013-2017. Print 2017 Jul. No abstract available.
PubMed 28679609Poinsot PA, Barrucand B, Ecarnot F, Lassalle P, Besch G, Chocron S, Perrotti A. Kinetics of endocan in patients undergoing cardiac surgery with and without cardiopulmonary bypass. Cytokine. 2018 Oct;110:328-332. doi: 10.1016/j.cyto.2018.03.040. Epub 2018 Apr 4.
PubMed 29627158Perrotti A, Chenevier-Gobeaux C, Ecarnot F, Bardonnet K, Barrucand B, Flicoteaux G, Lassalle P, Chocron S. Is Endocan a Diagnostic Marker for Pneumonia After Cardiac Surgery? The ENDOLUNG Study. Ann Thorac Surg. 2018 Feb;105(2):535-541. doi: 10.1016/j.athoracsur.2017.07.031. Epub 2017 Nov 11.
PubMed 29132699Madhivathanan PR, Fletcher N, Gaze D, Thomson R, Chandrasekaran V, Al-Subaie N, Valencia O, Sharma V. Perioperative kinetics of endocan in patients undergoing cardiac surgery with and without cardiopulmonary bypass. Cytokine. 2016 Jul;83:8-12. doi: 10.1016/j.cyto.2016.03.006. Epub 2016 Mar 19.
PubMed 26999704
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04616820
- Acronym / sponsor ID
- ENDOPULM / ENDOPULM
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Lung
- Keywords
- Endocan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Biothelis
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 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.
Endocan is a proteoglycan produced by the vascular endothelium. Animal studies suggested that the synthesis mainly happen in the pulmonary circulation, but this hypothesis has never been confirmed in humans.
Detailed description
The investigators will measure endocan levels in both pulmonary and systemic venous blood in patients undergoing on pump cardiac surgery.
The main objective is to quantify the difference of endocan blood level between the pulmonary and the systemic circulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients who are sheduled for on-pump coronary artery bypass surgery in the Cardiac Surgery Department of the University Hospital of Besancon.
Key inclusion criteria (2 listed)
- Planned on pump coronary artery bypass surgery
- Non opposition
Key exclusion criteria (12 listed)
- Age < 18 years old
- Emergent surgery
- Valvular replacement surgery
- Combined cardiac surgery
- Patients with inflammatory, infectious or evolutive neoplastic pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantify the difference of Endocan blood levels between pulmonary and systemic circulation at the end of cardiopulmonary bypass
Time frame: At the end of cardiopulmonary bypass
Blood samples will be collected at the same time in both pulmonary and systemic circulation at the end of cardiopulmonary bypass to measure Endocan blood level. The primary outcome will be the absolute difference between the Endocan blod level in the pulmonary circulation and in the systemic circulation.
1 secondary outcome
Kinetic of Endocan blood level in the systemic circulation during on pump cardiac surgery
Time frame: Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 8702785Lassalle P, Molet S, Janin A, Heyden JV, Tavernier J, Fiers W, Devos R, Tonnel AB. ESM-1 is a novel human endothelial cell-specific molecule expressed in lung and regulated by cytokines. J Biol Chem. 1996 Aug 23;271(34):20458-64. doi: 10.1074/jbc.271.34.20458.
- Background: PubMed 24108208Kao SJ, Chuang CY, Tang CH, Lin CH, Bien MY, Yu MC, Bai KJ, Yang SF, Chien MH. Plasma endothelial cell-specific molecule-1 (ESM-1) in management of community-acquired pneumonia. Clin Chem Lab Med. 2014 Mar;52(3):445-51. doi: 10.1515/cclm-2013-0638.
- Background: PubMed 25794660Palud A, Parmentier-Decrucq E, Pastre J, De Freitas Caires N, Lassalle P, Mathieu D. Evaluation of endothelial biomarkers as predictors of organ failures in septic shock patients. Cytokine. 2015 Jun;73(2):213-8. doi: 10.1016/j.cyto.2015.02.013. Epub 2015 Mar 17.
- Background: PubMed 21958978Mikkelsen ME, Shah CV, Scherpereel A, Lanken PN, Lassalle P, Bellamy SL, Localio AR, Albelda SM, Meyer NJ, Christie JD. Lower serum endocan levels are associated with the development of acute lung injury after major trauma. J Crit Care. 2012 Oct;27(5):522.e11-7. doi: 10.1016/j.jcrc.2011.07.077. Epub 2011 Sep 29.
- Background: PubMed 28679609Mangat M, Amalakuhan B, Habib S, Reyes LF, Hinojosa CA, Rodriguez AH, Soni NJ, Anzueto A, Levine SM, Peters JI, Aliberti S, Sibila O, Rello J, Witzenrath M, Waterer GW, Martin-Loeches I, Blanquer J, Sanz F, Marcos PJ, Sole-Violan J, Chalmers JD, Feldman C, Wunderink RG, Cruz CSD, Orihuela CJ, Restrepo MI. High endocan levels are associated with the need for mechanical ventilation among patients with severe sepsis. Eur Respir J. 2017 Jul 5;50(1):1700013. doi: 10.1183/13993003.00013-2017. Print 2017 Jul. No abstract available.
- Background: PubMed 29627158Poinsot PA, Barrucand B, Ecarnot F, Lassalle P, Besch G, Chocron S, Perrotti A. Kinetics of endocan in patients undergoing cardiac surgery with and without cardiopulmonary bypass. Cytokine. 2018 Oct;110:328-332. doi: 10.1016/j.cyto.2018.03.040. Epub 2018 Apr 4.
- Background: PubMed 29132699Perrotti A, Chenevier-Gobeaux C, Ecarnot F, Bardonnet K, Barrucand B, Flicoteaux G, Lassalle P, Chocron S. Is Endocan a Diagnostic Marker for Pneumonia After Cardiac Surgery? The ENDOLUNG Study. Ann Thorac Surg. 2018 Feb;105(2):535-541. doi: 10.1016/j.athoracsur.2017.07.031. Epub 2017 Nov 11.
- Background: PubMed 26999704Madhivathanan PR, Fletcher N, Gaze D, Thomson R, Chandrasekaran V, Al-Subaie N, Valencia O, Sharma V. Perioperative kinetics of endocan in patients undergoing cardiac surgery with and without cardiopulmonary bypass. Cytokine. 2016 Jul;83:8-12. doi: 10.1016/j.cyto.2016.03.006. Epub 2016 Mar 19.
- 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.
Pascal DEBAT study chair
CHU Jean Minjoz Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, 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 2 inclusion and 12 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 5 Feb 2021. 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 Guillaume Besch, MD (3 81 21 89 58 ext. +33, gbesch@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify the difference of Endocan blood levels between pulmonary and systemic circulation at the end of cardiopulmonary bypass (time frame: At 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?
On the ClinicalTrials.gov record for NCT04616820, which also lists 8 linked publications.
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 5 Feb 2021.