Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.

Postoperative Complications Clinical Trial

Official title:

Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. The ENDOLUNG Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02542423
• Other study ID #: CPP 15/479
• Status: Not yet recruiting
• Phase: N/A
• First received: September 1, 2015
• Last updated: September 3, 2015
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Sidney Chocron, MD Ph D
• Phone: +33381668662
• Email: sidney.chocron[@]univ-fcomte.fr
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Postoperative Complications
• Respiratory Distress Syndrome, Adult
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Endocan blood test samples

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from day -1 of the intervention to day 3, one blood sample per day	No