- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249246
Epidemiology of Sepsis in Turkish ICUs.
August 11, 2017 updated by: Nur Baykara
Epidemiology of Sepsis in Turkish ICUs :a National Point Prevalence Multi-centre Study.
The prevalence and mortality of sepsis in Turkey is not know at large.
Turkish Society of Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1499
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients (>18 yr)present on the participating ICU or admitted to participating ICUs on study day
Description
Inclusion Criteria:All patients present on or admitted to participating ICU on study day.
Exclusion Criteria:
- Age<18 years
- Patients who underwent cardiovascular surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infection only
The patients have only infection
|
|
Infection + SIRS
Patients have infection plus systemic inflammatory response syndrome (SIRS)
|
|
Severe sepsis
Septic patients with newly developed organ dysfunctions
|
|
Septic shock
Sepsis plus sepsis related hypotension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of sepsis
Time Frame: Up to 12 weeks.
|
The prevalence of sepsis,Severe sepsis and septic shock on study day
|
Up to 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality rate of sepsis
Time Frame: Mortality at 30 days
|
Mortality rate of septic shock
|
Mortality at 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25.
- Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.
- Falagas ME, Rafailidis PI, Kofteridis D, Virtzili S, Chelvatzoglou FC, Papaioannou V, Maraki S, Samonis G, Michalopoulos A. Risk factors of carbapenem-resistant Klebsiella pneumoniae infections: a matched case control study. J Antimicrob Chemother. 2007 Nov;60(5):1124-30. doi: 10.1093/jac/dkm356. Epub 2007 Sep 20.
- Baykara N, Akalin H, Arslantas MK, Hanci V, Caglayan C, Kahveci F, Demirag K, Baydemir C, Unal N; Sepsis Study Group. Epidemiology of sepsis in intensive care units in Turkey: a multicenter, point-prevalence study. Crit Care. 2018 Apr 16;22(1):93. doi: 10.1186/s13054-018-2013-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2016
Primary Completion (Actual)
January 28, 2016
Study Completion (Actual)
February 27, 2016
Study Registration Dates
First Submitted
August 9, 2017
First Submitted That Met QC Criteria
August 11, 2017
First Posted (Actual)
August 15, 2017
Study Record Updates
Last Update Posted (Actual)
August 15, 2017
Last Update Submitted That Met QC Criteria
August 11, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TurkishICS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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