NCT02930070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

October 9, 2016

Last Update Submit

October 11, 2016

Conditions

Sepsis

Keywords

sepsisqSOFASOFAdiagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    the mortality within 28 day of hospital stay

    28 day

Secondary Outcomes (2)

  • Duration of stay in the hospital

    28 day

  • Organ dysfunctions

    28 day

Study Arms (4)

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.

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.

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with infection in 10 selected general wards

You may qualify if:

  • Age\>=18;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical ICU,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26903338RESULT

  • 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.

    PMID: 26903336RESULT

  • 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.

    PMID: 26158402RESULT

  • 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.

    PMID: 30685579DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Weng, MD

    Medical ICU, Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingchao Luo, MD,phD

CONTACT

0086-13121021484sucapter@163.com

Jingchao Luo, MD,phD

CONTACT

8610-69155036sucapter@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2016

First Posted

October 11, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CN(2)