Plain English Summary
Background and study aims
Sepsis is a potentially life-threatening condition, in which the body’s immune system goes into overdrive in response to an infection, causing widespread inflammation (swelling). Severe sepsis is the name used when the sepsis causes one or more of the body’s systems, such as the heart, liver or kidneys, to stop working properly (organ failure). In order to prevent this, it is vital that sepsis is recognized and treated quickly, with appropriate escalation to critical care (emergency care) if required. It has also been found that a patient with sepsis is five times more likely to die than a patient who has suffered a heart attack or stroke. In the UK, sepsis is estimated to be responsible for about 37,000 deaths every year at a cost of £2.5 billion, which in Wales this could equate to a figure of 1,800 deaths and a cost of £125 million. Currently however, accurate data collection in the non-critical care setting is still under development in Wales and it is thought that the real number will be far higher. Sepsis is a major cause of avoidable deaths and it is essential that to understand the size of the problem within Wales so that the quality of care that patients receive can be improved. The aim of this study is to look at the prevalence (commonness) of sepsis across acute hospitals (hospitals with an emergency department) across Wales.
Who can participate?
Adults with suspected sepsis who have been admitted to an emergency department or critical care unit at participating hospitals in Wales.
What does the study involve?
Over a 24 hour period, study staff will monitor the number of adults who are admitted to one of the participating acute hospitals with suspected sepsis. The patients who have sepsis confirmed are asked to complete a questionnaire to measure their quality of life 6 years after they are discharged from hospital. Ninety days after the start of the study, all participants have their medical notes reviewed by the study team in order to find out the number of deaths.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants taking part in this study.
Where is the study run from?
Thirteen acute hospitals in Wales (UK)
When is the study starting and how long is it expected to run for?
June 2015 to February 2016
Who is funding the study?
1. Welsh Intensive Care Society (UK)
2. UK Sepsis Trust (UK)
3. Cwm Taf University Health Board (UK)
Who is the main contact?
Dr Tamas Szakmany
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tamas Szakmany
ORCID ID
http://orcid.org/0000-0003-3632-8844
Contact details
Department of Anaesthesia Intensive Care and Pain Medicine
Cardiff University
Cardiff
CF14 4XN
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3.1
Study information
Scientific title
The size of sepsis in Wales: Point prevalence study of sepsis in the acute hospital
Acronym
Study hypothesis
The aim of this study is to evaluate the prevalence of sepsis in acute hospitals in Wales.
Developing the digital data collection platform: http://www.ncbi.nlm.nih.gov/pubmed/27094989
Ethics approval
NRES Committee West Midlands - Solihull, 07/04/2015, ref: 15/WM/0095
Study design
Prospective observational multi-centre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Sepsis
Intervention
The study will test the prevalence of sepsis on the general wards and Emergency Departments over a 24 hour period. Data will be collected using an electronic data collection tool on basic demographics, whether patients fulfil sepsis criteria according to the 2012 Consensus Conference definitions and whether Sepsis 6 has been delivered to the patients. Those patients who are screened positive for sepsis will be invited to fill out a validated health-related quality of life questionnaire (SF-36) 6 months following hospital discharge.
Intervention type
Phase
Drug names
Primary outcome measure
1. Prevalence of sepsis in the acute hospital setting is determined by reviewing patient notes on the study day (24 hours)
2. Mortality rate of sepsis is measured by reviewing patient notes at 90 days
Secondary outcome measures
1. Quality of life of sepsis survivors is determined using SF-36 questionnaire at 6 months
2. Completion and barriers of Sepsis 6 are determined by reviewing patient notes on the study day (24 hours)
Overall trial start date
17/06/2015
Overall trial end date
28/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Must be admitted or transferred to either the ED or hospital ward or critical care area
2. NEWS score of 3 or above
3. High clinical suspicion of an infection
4. Have sepsis as defined by an infection together with two or more SIRS criteria
5. Aged 18 years or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Aged less than 18 years
Recruitment start date
17/06/2015
Recruitment end date
18/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glangwili General Hospital
Dolgwili Road
Carmarthen
SA31 2AF
United Kingdom
Trial participating centre
Morriston Hospital
Heol Maes Eglwys
Morriston
Swansea
SA6 6NL
United Kingdom
Trial participating centre
Nevill Hall Hospital
Brecon Road
Abergavenny
NP7 7EGA
United Kingdom
Trial participating centre
Prince Charles Hospital
Gurnos Road
Merthyr Tydfil
CF47 9DT
United Kingdom
Trial participating centre
Prince Philip Hospital
Bryngwyn Mawr Dafen Road
Llanelli
SA14 8QF
United Kingdom
Trial participating centre
Princess of Wales Hospital
Coity Road
Bridgend
CF31 1RQ
United Kingdom
Trial participating centre
Royal Glamorgan Hospital
Ynysmaerdy
Pntyclun
CF72 8XR
United Kingdom
Trial participating centre
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom
Trial participating centre
Singleton Hospital
Sketty Lane
Sketty
Swansea
SA2 8QA
United Kingdom
Trial participating centre
Withybush Hospital
Fishguard Road
Haverfordwest
SA61 2PZ
United Kingdom
Trial participating centre
Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
Trial participating centre
Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Trial participating centre
Ysbyty Glan Clwydd
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Funders
Funder type
Charity
Funder name
Welsh Intensive Care Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
UK Sepsis Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cwm Taf University Health Board
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
National and international conferences and publications.
Intention to publish date
31/12/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
1. 2015 results in http://www.sciencedirect.com/science/article/pii/S147330991500376X
2. 2016 results in http://jamia.oxfordjournals.org/content/23/6/1185
3. 2016 results in http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0167230