Perioperative Evaluation of Immuno-inflammatory Parameters

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 Overview

• Status: Terminated
• Conditions: Combined Inflammatory and Immunologic Defect

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cohort of patients

Description

Inclusion Criteria:

• Surgical patients (and controls)

Exclusion Criteria:

• Immune disorders

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Surgical cancer patients; No modification of the treatment
Non-surgical cancer patients; No modification of the treatment
Surgical non-cancer patients; No modification of the treatment
Non-surgical non-cancer patients; No modification of the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune parameters (immunocytes phenotype)	Function tests and surface markers	baseline up to 8 days (return to baseline)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Patrice Forget, M.D., UCL

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 2011/30MAI/218