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Endocan Blood Level in Pulmonary Circulation (ENDOPULM)

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ClinicalTrials.gov Identifier: NCT04616820
Recruitment Status : Not yet recruiting
First Posted : November 5, 2020
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
Biothelis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief 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.

Condition or disease
Cardiac Surgery Cardiopulmonary Bypass Lung

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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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


Biospecimen Retention:   Samples Without DNA
Endocan blood levels

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Planned on pump coronary artery bypass surgery
  • Non opposition

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04616820


Contacts
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Contact: Guillaume Besch, MD 3 81 21 89 58 ext +33 gbesch@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Biothelis
Investigators
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Study Chair: Pascal DEBAT CHU Jean Minjoz Besançon
More Information
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Publications:

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04616820    
Other Study ID Numbers: ENDOPULM
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Endocan