NCT04616820

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 5, 2021

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

October 30, 2020

Last Update Submit

February 4, 2021

Conditions

Keywords

Endocan

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the end of cardiopulmonary bypass

Secondary Outcomes (1)

  • Kinetic of Endocan blood level in the systemic circulation during on pump cardiac surgery

    Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Planned on pump coronary artery bypass surgery
  • Non opposition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 8702785BACKGROUND
  • Kao 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.

    PMID: 24108208BACKGROUND
  • Palud 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.

    PMID: 25794660BACKGROUND
  • Mikkelsen 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.

    PMID: 21958978BACKGROUND
  • Mangat 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.

    PMID: 28679609BACKGROUND
  • Poinsot 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.

    PMID: 29627158BACKGROUND
  • Perrotti 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.

    PMID: 29132699BACKGROUND
  • Madhivathanan 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.

    PMID: 26999704BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endocan blood levels

Study Officials

  • Pascal DEBAT

    CHU Jean Minjoz Besançon

    STUDY CHAIR

Central Study Contacts

Guillaume Besch, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 5, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share