Size of sepsis in Wales
| ISRCTN | ISRCTN78293101 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78293101 |
| Secondary identifying numbers | 3.1 |
- Submission date
- 30/12/2015
- Registration date
- 26/01/2016
- Last edited
- 25/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Department of Anaesthesia Intensive Care and Pain Medicine
Cardiff University
Cardiff
CF14 4XN
United Kingdom
 ORCID ID |
0000-0003-3632-8844 |
|---|
Study information
| Study design | Prospective observational multi-centre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | The size of sepsis in Wales: Point prevalence study of sepsis in the acute hospital |
| Study objectives | 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(s) | NRES Committee West Midlands - Solihull, 07/04/2015, ref: 15/WM/0095 |
| Health condition(s) or problem(s) studied | 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 | |
| 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 study start date | 17/06/2015 |
| Completion date | 28/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key exclusion criteria | Aged less than 18 years |
| Date of first enrolment | 17/06/2015 |
| Date of final enrolment | 18/06/2015 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Carmarthen
SA31 2AF
United Kingdom
Morriston
Swansea
SA6 6NL
United Kingdom
Abergavenny
NP7 7EGA
United Kingdom
Merthyr Tydfil
CF47 9DT
United Kingdom
Llanelli
SA14 8QF
United Kingdom
Bridgend
CF31 1RQ
United Kingdom
Pntyclun
CF72 8XR
United Kingdom
Newport
NP20 2UB
United Kingdom
Sketty
Swansea
SA2 8QA
United Kingdom
Haverfordwest
SA61 2PZ
United Kingdom
Wrexham
LL13 7TD
United Kingdom
Bangor
LL57 2PW
United Kingdom
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Sponsor information
Hospital/treatment centre
Ynysmeurig House Navigation Park
Abercynon
CF45 4SN
Wales
United Kingdom
"ROR" |
https://ror.org/00rh52j13 |
|---|
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | National and international conferences and publications. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No | |
| Results article | results | 01/11/2016 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/09/2017: Internal review.
02/12/2016: Publication references added.
