Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS

Peri-operative Clinical Trial

Official title:

Valeur Predictive de l'INVOS Sur l'Outcome Cardiaque en Post-opératoire. (French Title)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079454
• Other study ID #: invos0001
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: March 4, 2014
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female

• Age minimum 18 years old

Exclusion Criteria:

• Chronic renal failure

Related Conditions & MeSH terms

• Cardiac Outcome
• Invos
• Peri-operative

Locations

Country	Name	City	State
Belgium	cliniques universitaires St Luc	Brussels	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite measurement of major vascular events in the post-operative period	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