Perioperative Evaluation of Immuno-inflammatory Parameters

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01454856

Enrollment

Registered

2011-10-19

Start date

2011-10-31

Completion date

2016-09-30

Last updated

2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combined Inflammatory and Immunologic Defect

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Surgical patients (and controls)

Exclusion criteria

* Immune disorders

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Belgium

Outcome results