Defining sepsis on the wards

Not Applicable

Completed

• Conditions: Sepsis; Infections and Infestations

• Registration Number: ISRCTN86502304
• Lead Sponsor: Aneurin Bevan University Health Board

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29150856 results (added 12/06/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29637992 results (added 12/06/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30309393 results (added 12/06/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30544383 results (added 12/06/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31470569 results (added 13/03/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34376757/ results (added 12/08/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34704060/ (added 10/07/2023) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/35402727/ (added 10/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-17
• Study Completion: 2020-01-31
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1651

Inclusion Criteria

For the study day (0800 to 0759), consecutive patients presenting to the emergency department (ED) and acute hospital wards with sepsis related admission and patients presenting to the emergency department (ED) and acute hospital wards with acute ongoing sepsis will be enrolled. To be eligible patients must have all of the following:
1. Must be admitted or transferred to either the ED or hospital ward or critical care area.
2. Have a NEWS (National Early Warning) score of 3 or above
3. Have a high clinical suspicion of an infection
4. Have sepsis as defined by:
4.1. Either as infection together with two or more SIRS criteria (2012 definition)
4.2. Or as suspected or documented infection AND a proxy for organ dysfunction (i.e. acute increase of =2 SOFA (Sequential Organ Failure Assessment) points)

Exclusion Criteria

1. Patients less than 18 years of age
2. Patients in acute Mental Health wards

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of sepsis by both the 2012 Consensus definitions and the 3rd International Consensus Definitions. Measured on the day of the study in the Emergency Departments and general hospital wards.

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of the microbiology of sepsis linking the patient episode to the Public Health Wales/Public Health England microbiology database. Evaluated after 30 days of study entry.<br>2. Assessment of practice gaps in care of patients with sepsis by measuring compliance with the Sepsis 6 bundle.<br>3. To evaluate the impact of sepsis on patient outcome, particularly on long-term healthcare utilization (2 years post discharge) and quality of life (12 months post discharge) using linked healthcare data from the SAIL database. Mortality will be measured at 30, 90 days and 1 and 2 years following study entry. Quality of life will be assessed using the EQ-5D questionnaire during a telephone interview at 12 months.