qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis

Sepsis Clinical Trial

— qSOFAGAUGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02930070
• Other study ID #: qSOFA GAUGE
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2016
• Last updated: October 11, 2016
• Start date: September 2016
• Est. completion date: April 2017

Study information

• Verified date: October 2016
• Source: Peking Union Medical College Hospital
• Contact: Jingchao Luo, MD,phD
• Phone: 0086-13121021484
• Email: sucapter[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>=18;

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Medical ICU,Peking Union Medical College Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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.2015 — View 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 Consens — View 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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	the mortality within 28 day of hospital stay	28 day	Yes
Secondary	Duration of stay in the hospital	the duration of hospital stay with first 28 day	28 day	Yes
Secondary	Organ dysfunctions	the detailed items of SOFA to reflect major organ dysfunctions	28 day	Yes