Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04616820
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2020-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endocan Blood Level in Pulmonary Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Endocan blood levels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantify the difference of Endocan blood levels between pulmonary and systemic circulation at the end of cardiopulmonary bypass', 'timeFrame': 'At the end of cardiopulmonary bypass', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Kinetic of Endocan blood level in the systemic circulation during on pump cardiac surgery', 'timeFrame': 'Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endocan'], 'conditions': ['Cardiac Surgery', 'Cardiopulmonary Bypass', 'Lung']}, 'referencesModule': {'references': [{'pmid': '8702785', 'type': 'BACKGROUND', '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. doi: 10.1074/jbc.271.34.20458.'}, {'pmid': '24108208', 'type': 'BACKGROUND', 'citation': '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': '25794660', 'type': 'BACKGROUND', '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.'}, {'pmid': '21958978', 'type': 'BACKGROUND', '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.'}, {'pmid': '28679609', 'type': 'BACKGROUND', '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, 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': '29627158', 'type': 'BACKGROUND', '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.'}, {'pmid': '29132699', 'type': 'BACKGROUND', '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.'}, {'pmid': '26999704', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The investigators will measure endocan levels in both pulmonary and systemic venous blood in patients undergoing on pump cardiac surgery.\n\nThe main objective is to quantify the difference of endocan blood level between the pulmonary and the systemic circulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned on pump coronary artery bypass surgery\n* Non opposition\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Emergent surgery\n* Valvular replacement surgery\n* Combined cardiac surgery\n* Patients with inflammatory, infectious or evolutive neoplastic pulmonary disease\n* Patients with valvular problems, in particular aortic insufficiency\n* Patients who refuse to participate\n* Legal inability or disability\n* Patients who will probably not cooperate for the study\n* Pregnancy and/or breast feeding\n* Patients not in the Social security system\n* Patients in the exclusion period of another study'}, 'identificationModule': {'nctId': 'NCT04616820', 'acronym': 'ENDOPULM', 'briefTitle': 'Endocan Blood Level in Pulmonary Circulation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery', 'orgStudyIdInfo': {'id': 'ENDOPULM'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guillaume Besch, MD', 'role': 'CONTACT', 'email': 'gbesch@chu-besancon.fr', 'phone': '3 81 21 89 58', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Pascal DEBAT', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Jean Minjoz Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biothelis', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}