qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=18; Exclusion Criteria: Hospital stay less than 24h just for chemotherapy,biotherapy or endoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| qSOFA(+)SOFA(+)<br>Infection patients who has a qSOFA>=2 and SOFA>=2 in a same day within 28 day of hospital stay.This group has the greatest priority in the competition of inclusion of groups. | |
| qSOFA(-)SOFA(+)<br>Infection patients who has a qSOFA<2 and SOFA>=2 in a same day within 28 day of hospital stay.This group has the secondary priority in the competition of inclusion of groups. | |
| qSOFA(+)SOFA(-)<br>Infection patients who has a qSOFA>=2 and SOFA<2 in a same day within 28 day of hospital stay.This group has the third priority in the competition of inclusion of groups. | |
| qSOFA(-)SOFA(-)<br>Infection patients who has a qSOFA<2 and SOFA<2 in a same day within 28 day of hospital stay.This group has the least priority in the competition of inclusion of groups. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | the mortality within 28 day of hospital stay | 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of stay in the hospital | the duration of hospital stay with first 28 day | 28 day | 
| Organ dysfunctions | the detailed items of SOFA to reflect major organ dysfunctions | 28 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, qSOFA, SOFA, diagnostic accuracy