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OpenTrials
Completed

NCT Number: NCT04114214

Objective Sepsis Identification Tool to Study Sepsis Epidemiology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Classification of Sepsis

    Time frame: within 2 days of microbiological sampling

    comparison with clinician review of case notes

Secondary outcomes

  1. Organ Dysfunction

    Time frame: within 2 days of microbiological sampling

    Estimated Organ Dysfunction from sequential organ failure assessment

  2. 28 Day Mortality

    Time frame: 28 days

    28 Day Mortality of Hospital Episode

  3. Hospital Length of Stay

    Time frame: 1 year

    Hospital Length of Stay of Hospital Episode

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2019
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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