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Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery

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ClinicalTrials.gov Identifier: NCT01921049
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Wolfgang A. Wetsch, University of Cologne

Brief Summary:
Patients undergoing major procedures in oral and maxillofacial surgery more often develop a systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical care therapy than patients with a comparable major surgery in other regions. The reasons for this finding are unknown and have not been studied in depth so far. We hypothesize that surgical trauma in this region might activate pro-inflammatory pathways. By examining the proteome of patients at different stages (prior to the surgery, at ICU admission, on the second postoperative day and when SIRS has ended clinically), we aim to identify the involved pro-inflammatory pathways and identify possible target proteins that might be clues to modification of postoperative SIRS in the future.

Condition or disease
Systemic Inflammatory Response Syndrome (SIRS)

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014



Primary Outcome Measures :
  1. change of concentration of pro-inflammatory cytokines [µg/l] [ Time Frame: up to 10 days post surgery ]
    Change of concentration of pro-inflammatory cytokines from pre-operative sample over icu-admission, 2nd postoperative day and clinical end of SIRS.


Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients undergoing major procedures in oral and maxillofacial surgery during the study period
Criteria

Inclusion Criteria:

  • age 18-99yrs
  • scheduled for elective surgery with risk for development of SIRS
  • written and informed consent

Exclusion Criteria:

  • age <18yrs
  • pregnancy
  • emergency surgery
  • failure to obtain patient consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921049


Locations
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Germany
Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Wolfgang A. Wetsch, M.D. Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne

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Responsible Party: Dr. Wolfgang A. Wetsch, M.D., University of Cologne
ClinicalTrials.gov Identifier: NCT01921049     History of Changes
Other Study ID Numbers: 13-229
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Syndrome
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Inflammation
Shock