Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.

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

According to literature data, Endocan can detect the onset of respiratory failure. The investigators aim to prove its value also for cardiac surgery patients.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Respiratory Failure
• Intervention / Treatment: Other: Endocan blood test samples

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients undergoing cardiac surgery	Other: Endocan blood test samples; Other Names: Endocan; Endolung

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Postoperative Complications
• Other Study ID Numbers: CPP 15/479