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Clinical Trials/NCT04114214
NCT04114214
Completed
Not Applicable

Development of an Objective Sepsis Identification Tool to Study Sepsis Epidemiology: a Single Center Retrospective Cohort Study

Chinese University of Hong Kong1 site in 1 country490 target enrollmentSeptember 10, 2019
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Chinese University of Hong Kong
Enrollment
490
Locations
1
Primary Endpoint
Classification of Sepsis
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed Description

Globally, sepsis affects an estimated 31.5 million people and accounts for 5.3 million deaths each year. The incidence of sepsis is increasing and is now a more common cause for hospital admission than acute myocardial infarction and stroke. However this apparent improvement in sepsis outcomes may also be due to changes in definition and reporting of sepsis. The latest Sepsis-3 definition outlines sepsis as life-threatening organ dysfunction due to dysregulated host response to infection. Trends on sepsis incidence and outcome were based on previous definitions of sepsis. Furthermore, changes in coding practices and documentation for hospital claims may cause misleading changes in incidence and outcomes. Electronic health record clinical data provides more reliable data on sepsis epidemiology than diagnostic coding accounts for. Our understanding of sepsis epidemiology is based on studies from high income western countries. Even within these countries, health expenditure and resources vary which may affect sepsis outcomes. Current data on the burden of sepsis from the rest of the world is insufficient. Hong Kong is well poised to provide these lacking data on the epidemiology of sepsis. More than 90% of inpatient care is provided by the public healthcare system and would be captured by the electronic Clinical Management System. 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.

Registry
clinicaltrials.gov
Start Date
September 10, 2019
End Date
October 15, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lowell Ling

Clinical Lecturer

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • January 2018 to February 2018 adult inpatients at Prince of Wales Hospital
  • 1st microbiological culture tests during hospital admission

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Classification of Sepsis

Time Frame: within 2 days of microbiological sampling

comparison with clinician review of case notes

Secondary Outcomes

  • 28 Day Mortality(28 days)
  • Organ Dysfunction(within 2 days of microbiological sampling)
  • Hospital Length of Stay(1 year)

Study Sites (1)

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