NCT02448472

Brief Summary

Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In China, the MDRO is much higher than western country. There is no study about the epidemiology of sepsis in China. Therefore, it is necessary to conduct a study about it in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

April 11, 2015

Last Update Submit

February 14, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence

    Patients will be assessed up to 90 days

  • Mortality

    Sepsis and severe sepsis patients will be assessed up to 90 days

Secondary Outcomes (1)

  • etiology

    The pathogen of sepsis will be assessed up to 90 days

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sepsis patient who admitted into ICU

You may qualify if:

  • sepsis patients who admitted into ICU during research period (include patients with sepsis at ICU admission and patients who has new sepsis during ICU period)

You may not qualify if:

  • The patients with second sepsis in ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (2)

  • Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155.

  • Yang Y, Xie JF, Yu KJ, Yao C, Li JG, Guan XD, Yan J, Ma XC, Kang Y, Yang CS, Yao XQ, Shang HC, Qiu HB; for CHESS Study Investigators. Epidemiological Study of Sepsis in China: Protocol of a Cross-sectional Survey. Chin Med J (Engl). 2016 Dec 20;129(24):2967-2973. doi: 10.4103/0366-6999.195474.

MeSH Terms

Conditions

Sepsis

Interventions

Observation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Yang Yi, Ph.D.

    Zhongda Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

April 11, 2015

First Posted

May 19, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 17, 2016

Record last verified: 2015-10

Locations