Impact of Hyperoxia During Cardiopulmonary (CARDIOX)

April 9, 2019 updated by: Centre Hospitalier Universitaire, Amiens

Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery

The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie
      • Dijon, France, 21079
        • Chu Dijon-Bourgogne

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major patient ≥ 18 years
  • Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
  • Signed Consent
  • Affiliation to social security

Exclusion Criteria:

  • Permanent atrial fibrillation
  • Cordarone therapy,
  • Pregnant woman
  • Patient under guardianship or trusteeship or private public law
  • Internal pacemaker
  • Hypothermia,
  • Patient refusal,
  • Cardiac surgery without extracorporal circulation (ECC),
  • Participation in 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normoxia
During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
Drug: medical oxygen
Active Comparator: hyperoxia
During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
Drug: medical oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Time Frame: 15 days after surgery
15 days after surgery

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Osama Abou Arab, Doctor, CHU Amiens-Picardie

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 (Actual)

November 11, 2014

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2014_843_0006
  • 2014-001403-44 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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