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

NCT02079454 | Completed

• 1 other identifier: invos0001
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invos; Peri-operative; Cardiac Outcome

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with high cardiac comorbidities undergoing a general anesthesia for a surgery of over two hours with bleding potential.

You may qualify if:

• Male and female
• Age minimum 18 years old

You may not qualify if:

• Chronic renal failure

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

cliniques universitaires St Luc

Brussels, Brabant, 1200, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for troponin I measurement

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: March 5, 2014
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

BE (1)