Perioperative Evaluation of Immuno-inflammatory Parameters

Combined Inflammatory and Immunologic Defect Clinical Trial

Official title:

Perioperative Evaluation of Immuno-inflammatory Parameters

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01454856
• Other study ID #: 2011/30MAI/218
• Status: Terminated
• Phase: N/A
• First received: October 5, 2011
• Last updated: March 23, 2017
• Start date: October 2011
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgical patients (and controls)

Exclusion Criteria:

• Immune disorders

Related Conditions & MeSH terms

• Combined Inflammatory and Immunologic Defect
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune parameters (immunocytes phenotype)	Function tests and surface markers	baseline up to 8 days (return to baseline)
Secondary	Long term outcome	General morbidity and mortality	5 years
Secondary	Coagulation parameters (like platelet function) (substudy)	Function tests and surface markers	perioperative period (up to 3 days)
Secondary	Inflammatory markers (cytokines) (substudy)	Intracellular FACS and ELISA measures	baseline up to 8 days (return to baseline)