NCT04114214

Brief Summary

Globally, sepsis affects an estimated 31.5 million people and accounts for 5.3 million deaths each year. This calculation is based on data from western high income countries only. The purpose of this study is to develop an objective sepsis identification tool using electronic health records to study the epidemiology of sepsis in Hong Kong.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

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

Study Start

First participant enrolled

September 10, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

October 1, 2019

Last Update Submit

May 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Classification of Sepsis

    comparison with clinician review of case notes

    within 2 days of microbiological sampling

Secondary Outcomes (3)

  • Organ Dysfunction

    within 2 days of microbiological sampling

  • 28 Day Mortality

    28 days

  • Hospital Length of Stay

    1 year

Study Arms (1)

patients with suspected infection or sepsis

All patients admitted with suspected infection or sepsis from January 2018 to February 2018 at Prince of Wales Hospital

Eligibility Criteria

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

All adult patients admitted to Prince of Wales Hospital in Hong Kong between January 2018 to February 2018 with suspected infection.

You may qualify if:

  • January 2018 to February 2018 adult inpatients at Prince of Wales Hospital
  • st microbiological culture tests during hospital admission

You may not qualify if:

  • duplicated microbiological sampling
  • missing values for sequential organ failure assessment score calculation
  • microbiological tests were for screening only (methicillin-resistant staphylococcus aureus swabs, vancomycin resistant Enterococci rectal swab)
  • antibiotics not started 2 days before or after first microbiological sampling
  • antibiotics duration less than 4 days unless death
  • not given antibiotics on discharge if given less than 4 days antibiotics in hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Liu YZ, Chu R, Lee A, Gomersall CD, Zhang L, Gin T, Chan MTV, Wu WKK, Ling L. A surveillance method to identify patients with sepsis from electronic health records in Hong Kong: a single centre retrospective study. BMC Infect Dis. 2020 Sep 7;20(1):652. doi: 10.1186/s12879-020-05330-x.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 3, 2019

Study Start

September 10, 2019

Primary Completion

October 10, 2019

Study Completion

October 15, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations