Condition category
Infections and Infestations
Date applied
30/12/2015
Date assigned
26/01/2016
Last edited
02/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Cwm Taf University Health Board

Sponsor details

Ynysmeurig House Navigation Park
Abercynon
CF45 4SN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in http://www.sciencedirect.com/science/article/pii/S147330991500376X
2016 results in http://jamia.oxfordjournals.org/content/23/6/1185
2016 results in http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0167230

Publication citations

Additional files

Editorial Notes

02/12/2016: Publication references added.