- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079454
Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS
Valeur Predictive de l'INVOS Sur l'Outcome Cardiaque en Post-opératoire. (French Title)
Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery.
The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering.
The idea is to prevent per and foremostpost-operative myocardial necrosis complications by acting as soon as we have an INVOS drop during anesthesia.
The "cardiac events" will be monitored and defined according to the EHA (european heart association) guidelines.
(Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored per and post operatively.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Brabant
-
Brussels, Brabant, Belgium, 1200
- Cliniques Universitaires St Luc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female
- Age minimum 18 years old
Exclusion Criteria:
- Chronic renal failure
Study Plan
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 |
|---|---|---|
|
A composite measurement of major vascular events in the post-operative period
Time Frame: 96 hours post-operative
|
Myocardial infarction (measured by positivation of troponin I assay above the defined threshold) associated with clinical data (pain, dyspnea,...) or ST modification on the EKG or apparition of a new LBBB, or new wall abnormalities on the TTE. Or new TIAs or CVAs |
96 hours post-operative
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- invos0001
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.