Clinical trial NCT02930070: qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis
Official title: Diagnostic Accuracy of qSOFA Score for the Diagnosis of Sepsis in General Wards: a Single Center Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
qSOFA
SOFA
diagnostic accuracy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infection in 10 selected general wards

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.

Eligibility criteria: Inclusion Criteria:

* Age\>=18;

Exclusion Criteria:

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

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 day
Secondary outcomes:
measure: Duration of stay in the hospital
timeFrame: 28 day
measure: Organ dysfunctions
timeFrame: 28 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Medical ICU,Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Medical ICU, Peking Union Medical College Hospital
name: Li Weng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
citation: Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.
citation: Churpek MM, Zadravecz FJ, Winslow C, Howell MD, Edelson DP. Incidence and Prognostic Value of the Systemic Inflammatory Response Syndrome and Organ Dysfunctions in Ward Patients. Am J Respir Crit Care Med. 2015 Oct 15;192(8):958-64. doi: 10.1164/rccm.201502-0275OC.
citation: Luo J, Jiang W, Weng L, Peng J, Hu X, Wang C, Liu G, Huang H, Du B. Usefulness of qSOFA and SIRS scores for detection of incipient sepsis in general ward patients: A prospective cohort study. J Crit Care. 2019 Jun;51:13-18. doi: 10.1016/j.jcrc.2019.01.012. Epub 2019 Jan 18.