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Objective Sepsis Identification Tool to Study Sepsis Epidemiology

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ClinicalTrials.gov Identifier: NCT04114214
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Lowell Ling, Chinese University of Hong Kong

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of an Objective Sepsis Identification Tool to Study Sepsis Epidemiology: a Single Center Retrospective Cohort Study
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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



Primary Outcome Measures :
  1. Classification of Sepsis [ Time Frame: within 2 days of microbiological sampling ]
    comparison with clinician review of case notes


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114214


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lowell Ling, Clinical Lecturer, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04114214    
Other Study ID Numbers: 2019.214
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes