NCT02542423

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

September 1, 2015

Last Update Submit

September 3, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients undergoing cardiac surgery

OTHER
Other: Endocan blood test samples

Interventions

Also known as: Endocan, Endolung
patients undergoing cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chazal E, Morin L, Chocron S, Lassalle P, Pili-Floury S, Salomon du Mont L, Ferreira D, Samain E, Perrotti A, Besch G. Impact of early postoperative blood glucose variability on serum endocan level in cardiac surgery patients: a sub study of the ENDOLUNG observational study. Cardiovasc Diabetol. 2023 Aug 24;22(1):221. doi: 10.1186/s12933-023-01959-5.

MeSH Terms

Conditions

Respiratory InsufficiencyPostoperative Complications

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sidney Chocron, MD Ph D

CONTACT

Andrea Perrotti, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

September 7, 2015

Record last verified: 2015-09