Perioperative Evaluation of Immuno-inflammatory Parameters

Terminated

• Conditions: Combined Inflammatory and Immunologic Defect

• Registration Number: NCT01454856
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected.

This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

Detailed Description

A significant number of published data can be concluded that surgery and anesthetic and analgesic techniques have an impact on immunity and inflammation.

However, none of these studies have been performed with modern techniques, much more reliable evaluation of immune activity, such as the assessment of monocytic degranulation by flow cytometry.

It is therefore important to document immune activity using these new techniques, our patients, perioperative. This will be analyzed, so observational, the potential impact of different therapeutic interventions the patient receives.

This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected.

This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-19
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Surgical patients (and controls)

Exclusion Criteria

• Immune disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune parameters (immunocytes phenotype)	baseline up to 8 days (return to baseline)	Function tests and surface markers

Secondary Outcome Measures

Name	Time	Method
Long term outcome	5 years	General morbidity and mortality
Coagulation parameters (like platelet function) (substudy)	perioperative period (up to 3 days)	Function tests and surface markers
Inflammatory markers (cytokines) (substudy)	baseline up to 8 days (return to baseline)	Intracellular FACS and ELISA measures

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium