search
Back to results

Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.

Primary Purpose

Respiratory Failure, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endocan blood test samples
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to give written consent
  • Elective cardiac surgery
  • More than 18 years old

Exclusion Criteria:

  • Less than 18 years old
  • urgency / emergency cardiac surgery
  • pregnancy
  • refusal
  • unable to give written consent
  • oncologic patients
  • concomitant inflammatory or infective pulmonary disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    patients undergoing cardiac surgery

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes of Endocan blood levels after cardiac surgery and its correlation with postoperative pulmonary failure
    The investigators will enroll 150 patients undergoing elective cardiac surgery. Every participant will be prelevated of several blood samples following this time frame : day -1 from intervention, day 0 ( six hours after intervention), day 1 , day 2 , day 3. All patients will be observed to detect all infections, especially pulmonary ones, up to hospital discharge. Endocan blood levels of patients developing pulmonary failure and patients without postoperative respiratory insufficiency will be compared.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2015
    Last Updated
    September 3, 2015
    Sponsor
    Centre Hospitalier Universitaire de Besancon
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02542423
    Brief Title
    Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
    Official Title
    Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. The ENDOLUNG Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients.
    Detailed Description
    Endocan is an endothelium derived soluble dermatan sulfate proteoglycan. Literature data shows that alterate levels of its blood concentration correlate with the onset of pulmonary failure in patients with major trauma and septic shock. In cardiac surgery respiratory failure and infections are threatening complications leading to mortality rates up to 80%. A rapid diagnosis and treatment of this pathology is crucial to improve the clinical outcome. Unfortunately specific data for the efficacy of Endocan predictive value in cardiac surgery patients are not available. The investigators aim to determinate if Endocan can be a helpful tool to identify patients developing acute respiratory failure after cardiac surgery and anticipate specific treatment in order to improve survival.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Postoperative Complications

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients undergoing cardiac surgery
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Endocan blood test samples
    Other Intervention Name(s)
    Endocan, Endolung
    Primary Outcome Measure Information:
    Title
    Changes of Endocan blood levels after cardiac surgery and its correlation with postoperative pulmonary failure
    Description
    The investigators will enroll 150 patients undergoing elective cardiac surgery. Every participant will be prelevated of several blood samples following this time frame : day -1 from intervention, day 0 ( six hours after intervention), day 1 , day 2 , day 3. All patients will be observed to detect all infections, especially pulmonary ones, up to hospital discharge. Endocan blood levels of patients developing pulmonary failure and patients without postoperative respiratory insufficiency will be compared.
    Time Frame
    from day -1 of the intervention to day 3, one blood sample per day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to give written consent Elective cardiac surgery More than 18 years old Exclusion Criteria: Less than 18 years old urgency / emergency cardiac surgery pregnancy refusal unable to give written consent oncologic patients concomitant inflammatory or infective pulmonary disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sidney Chocron, MD Ph D
    Phone
    +33381668662
    Email
    sidney.chocron@univ-fcomte.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Perrotti, MD
    Phone
    +33381669416
    Email
    a.perrotti@hotmail.it

    12. IPD Sharing Statement

    Learn more about this trial

    Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.

    We'll reach out to this number within 24 hrs