Endocan Blood Level in Pulmonary Circulation

Cardiac Surgery Clinical Trial

— ENDOPULM  

Official title:

Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04616820
• Other study ID #: ENDOPULM
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Guillaume Besch, MD
• Phone: 3 81 21 89 58
• Email: gbesch[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Lung

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Biothelis

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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, Solé-Violán 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). pii: 1700013. doi: 10.1183/13993003.00013-2017. Print 2017 Jul. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery