qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis

NCT ID: NCT02930070

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

qSOFA(+)SOFA(+)

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.

No interventions assigned to this group

qSOFA(-)SOFA(+)

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.

No interventions assigned to this group

qSOFA(+)SOFA(-)

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.

No interventions assigned to this group

qSOFA(-)SOFA(-)

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age>=18;

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Weng, MD

Role: PRINCIPAL_INVESTIGATOR

Medical ICU, Peking Union Medical College Hospital

Locations

Medical ICU,Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingchao Luo, MD,phD

Role: CONTACT

sucapter@163.com

0086-13121021484

Jingchao Luo, MD,phD

Role: CONTACT

sucapter@163.com

8610-69155036

Facility Contacts

Bin Du, MD

Role: primary

dubin98@gmail.com

8610-6915-5036

Li Weng, MD

Role: backup

wengli@pumch.cn

8610-6915-4035

Bin Du, MD

Role: primary

dubin98@gmail.com

8610-6915-5036

Li Weng, MD

Role: backup

wengli@pumch.cn

8610-6915-4035

References

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.

Reference Type: RESULT

PMID: 26903338 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26903336 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26158402 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30685579 (View on PubMed)

Other Identifiers

qSOFA GAUGE

Identifier Type: -

Identifier Source: org_study_id