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qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis

Diagnostic Accuracy of qSOFA Score for the Diagnosis of Sepsis in General Wards: a Single Center Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02930070
Acronym
qSOFAGAUGE
Enrollment
4000
Registered
2016-10-11
Start date
2016-09-30
Completion date
2017-04-30
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, qSOFA, SOFA, diagnostic accuracy

Brief summary

The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general wards. Despite an alternative process by using a simplified qSOFA score, many patients may still be left out. Whether these patients matter or not is unknown. This prospective cohort includes patients from ten general wards with high incidence of infection during a consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore to compare patients under different groups, eventually to evaluate the diagnostic accuracy of qSOFA score in diagnosis of sepsis.

Detailed description

The sepsis, which is considered as multi-organ dysfunction induced by infection, is a one of leading causes of death in hospital. In 2016, the third international consensus has modified the definition of sepsis from infection with \>=2 of systemic inflammatory response syndrome (SIRS) criteria to infection with \>=2 of sequential organ failure assessment (SOFA) score. This new definition, which well reflects the organ dysfunction nature of sepsis, however makes it difficult to diagnose sepsis in general wards. An alternative of process was put forward to compensate this weakness. For each infection patient in general, access a quick SOFA (qSOFA), if it is above 2 score, then conduct laboratory examination to get a SOFA score. This process is helpful to find out sepsis, but undoubtedly leave out some patients who meet the SOFA criteria without qSOFA \>=2. Besides, there are also some patients who has a qSOFA \>=2 however do not meet the SOFA criteria. Whether those patients have better survival rate is unclear. This prospective cohort is aimed to compare prognosis of patients with different SOFA, qSOFA score, therefore access the diagnostic accuracy of qSOFA in the diagnosis of sepsis, eventually evaluate the feasibility of using qSOFA as a complete replacement of SOFA in general wards.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age\>=18;

Exclusion criteria

* Hospital stay less than 24h just for chemotherapy,biotherapy or endoscopy.

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28 daythe mortality within 28 day of hospital stay

Secondary

MeasureTime frameDescription
Duration of stay in the hospital28 daythe duration of hospital stay with first 28 day
Organ dysfunctions28 daythe detailed items of SOFA to reflect major organ dysfunctions

Countries

China

Contacts

Primary ContactJingchao Luo, MD,phD
sucapter@163.com0086-13121021484
Backup ContactJingchao Luo, MD,phD
sucapter@163.com8610-69155036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026