Objective Sepsis Identification Tool to Study Sepsis Epidemiology

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis

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.

• Study Type: Observational
• Enrollment (Actual): 490

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of Sepsis	comparison with clinician review of case notes	within 2 days of microbiological sampling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ Dysfunction	Estimated Organ Dysfunction from sequential organ failure assessment	within 2 days of microbiological sampling
28 Day Mortality	28 Day Mortality of Hospital Episode	28 days
Hospital Length of Stay	Hospital Length of Stay of Hospital Episode	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2019.214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No