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

Systemic Inflammatory Response Syndrome (SIRS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921049
• Other study ID #: 13-229
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: December 7, 2014
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Syndrome
• Systemic Inflammatory Response Syndrome
• Systemic Inflammatory Response Syndrome (SIRS)

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No