Systemic Inflammatory Response Syndrome (SIRS)NCT01921049
Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery
An observational study of Systemic Inflammatory Response Syndrome (SIRS), run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS)
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients undergoing major procedures in oral and maxillofacial surgery during the study period
Who may be able to join
- age 18-99yrs
- scheduled for elective surgery with risk for development of SIRS
- written and informed consent
Who cannot join
- age <18yrs
- pregnancy
- emergency surgery
- failure to obtain patient consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
Cologne
About this study
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.
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wolfgang A. Wetsch, University of Cologne
- Investigators
- Wolfgang A. Wetsch, M.D., Principal investigator, Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921049
- Sponsor's protocol ID
- 13-229
- Status last verified
- Dec 2014
- First submitted
- 6 Aug 2013
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT01921049
- Acronym / sponsor ID
- 13-229
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients undergoing major procedures in oral and maxillofacial surgery during the study period
Key inclusion criteria (3 listed)
- age 18-99yrs
- scheduled for elective surgery with risk for development of SIRS
- written and informed consent
Key exclusion criteria (4 listed)
- age <18yrs
- pregnancy
- emergency surgery
- failure to obtain patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang A. Wetsch, M.D. principal investigator
Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome (SIRS), run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of concentration of pro-inflammatory cytokines [µg/l] (time frame: up to 10 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.