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
About this trial
This is an interventional diagnostic trial for Respiratory Failure
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
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
NCT ID
NCT02542423
First Posted
September 1, 2015
Last Updated
September 3, 2015
Sponsor
Centre Hospitalier Universitaire de Besancon
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