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

NCT01921049 | Completed

• 1 other identifier: 13-229
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Response Syndrome (SIRS)

Outcome Measures

Primary Outcomes (1)

• change of concentration of pro-inflammatory cytokines [µg/l]

  Change of concentration of pro-inflammatory cytokines from pre-operative sample over icu-admission, 2nd postoperative day and clinical end of SIRS.

  up to 10 days post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients undergoing major procedures in oral and maxillofacial surgery during the study period

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne

Cologne, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Wolfgang A. Wetsch, M.D.

  Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 13, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

DE (1)