SepsisNCT03249246
Epidemiology of Sepsis in Turkish ICUs.
An observational study of Sepsis and Septic Shock, run by Nur Baykara.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Severe Sepsis
- How many people
- 1,499 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2016to 27 Feb 2016
- 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 (>18 yr)present on the participating ICU or admitted to participating ICUs on study day
Who may be able to join
None listed.
Who cannot join
- Age<18 years
- Patients who underwent cardiovascular surgery.
About this study
Official title: 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.
- Conditions
- Sepsis, Septic Shock, Severe Sepsis
- Being tested
- No intervention
- Keywords
- Sepsis, ICU, Point prevalence
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Infection only | The patients have only infection Receives: Other: No intervention | |
| Infection + SIRS | Patients have infection plus systemic inflammatory response syndrome (SIRS) Receives: Other: No intervention | |
| Severe sepsis | Septic patients with newly developed organ dysfunctions Receives: Other: No intervention | |
| Septic shock | Sepsis plus sepsis related hypotension Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sepsis
The prevalence of sepsis,Severe sepsis and septic shock on study day
Measured: Up to 12 weeks.
Secondary outcomes (1)
Mortality rate of sepsis
Mortality rate of septic shock
Measured: Mortality at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start27 Jan 2016
- Primary completion28 Jan 2016
- Study completion27 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Cross-sectional
- Enrolment
- 1,499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nur Baykara
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Intensive Care, Sepsis Study Group
- Responsible party
- Sponsor-investigator, Nur Baykara, Turkish Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249246
- Sponsor's protocol ID
- TurkishICS
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26109396Falagas 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.
PubMed 17884829Fleischmann 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.
PubMed 26414292Baykara 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.
PubMed 29656714
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Sepsis in Turkish ICUs :a National Point Prevalence Multi-centre Study.
- ClinicalTrials.gov ID
- NCT03249246
- Acronym / sponsor ID
- TurkishICS
- Conditions
- Sepsis, Septic Shock, Severe Sepsis
- Keywords
- Sepsis, ICU, Point prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,499 participants (actual)
- Lead sponsor
- Nur BaykaraUniversity, hospital or other
- Collaborators
- Turkish Society of Intensive Care, Sepsis Study Group
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 28 Jan 2016 (actual)
- Study completion
- 27 Feb 2016 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infection only | – | Other: No interventionThe patients have only infection |
| Infection + SIRS | – | Other: No interventionPatients have infection plus systemic inflammatory response syndrome (SIRS) |
| Severe sepsis | – | Other: No interventionSeptic patients with newly developed organ dysfunctions |
| Septic shock | – | Other: No interventionSepsis plus sepsis related hypotension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients (>18 yr)present on the participating ICU or admitted to participating ICUs on study day
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Age<18 years
- Patients who underwent cardiovascular surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Infection + SIRS, Infection only, Septic shock, Severe sepsis |
Primary outcome
Prevalence of sepsis
Time frame: Up to 12 weeks.
The prevalence of sepsis,Severe sepsis and septic shock on study day
1 secondary outcome
Mortality rate of sepsis
Time frame: Mortality at 30 days
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 15 Aug 2017.
- Background: PubMed 26109396Rhodes 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.
- Background: PubMed 17884829Falagas 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.
- Results publication: PubMed 26414292Fleischmann 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.
- Derived from this study: PubMed 29656714Baykara 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Nur Baykara.
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 0 inclusion and 2 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence of sepsis (time frame: Up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249246, which also lists 4 linked publications.
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 15 Aug 2017.