Endocan Blood Level in Pulmonary Circulation (ENDOPULM)

February 4, 2021 updated by: Centre Hospitalier Universitaire de Besancon

Venous Pulmonary Compared to Venous Systemic Blood Level of Endocan During On-pump Cardiac Surgery

Endocan is a proteoglycan produced by the vascular endothelium. Animal studies suggested that the synthesis mainly happen in the pulmonary circulation, but this hypothesis has never been confirmed in humans.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators will measure endocan levels in both pulmonary and systemic venous blood in patients undergoing on pump cardiac surgery.

The main objective is to quantify the difference of endocan blood level between the pulmonary and the systemic circulation.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include adult patients who are sheduled for on-pump coronary artery bypass surgery in the Cardiac Surgery Department of the University Hospital of Besancon.

Description

Inclusion Criteria:

  • Planned on pump coronary artery bypass surgery
  • Non opposition

Exclusion Criteria:

  • Age < 18 years old
  • Emergent surgery
  • Valvular replacement surgery
  • Combined cardiac surgery
  • Patients with inflammatory, infectious or evolutive neoplastic pulmonary disease
  • Patients with valvular problems, in particular aortic insufficiency
  • Patients who refuse to participate
  • Legal inability or disability
  • Patients who will probably not cooperate for the study
  • Pregnancy and/or breast feeding
  • Patients not in the Social security system
  • Patients in the exclusion period of another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify the difference of Endocan blood levels between pulmonary and systemic circulation at the end of cardiopulmonary bypass
Time Frame: At the end of cardiopulmonary bypass
Blood samples will be collected at the same time in both pulmonary and systemic circulation at the end of cardiopulmonary bypass to measure Endocan blood level. The primary outcome will be the absolute difference between the Endocan blod level in the pulmonary circulation and in the systemic circulation.
At the end of cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinetic of Endocan blood level in the systemic circulation during on pump cardiac surgery
Time Frame: Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery
Blood samples will be collected in the systemic circulation prior to the start of cardiopulmonary bypass, at the beginning of the cardiopulmonary bypass and at the end of cardiopulmonary bypass, and at the end of the surgery
Prior to the start of cardiopulmonary bypass, at the beginning and at the end of cardiopulmonary bypass, and at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Biothelis

Investigators

  • Study Chair: Pascal DEBAT, Chu Jean Minjoz Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENDOPULM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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