GenOMICC study - Looking at DNA of patients with severe illness and injury to find the genes that cause some people to become very unwell and be admitted to intensive care
ISRCTN | ISRCTN16993428 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN16993428 |
IRAS number | 189676 |
Secondary identifying numbers | IRAS 189676 (Scotland), IRAS 269326 (England/Wales) |
- Submission date
- 01/06/2021
- Registration date
- 25/06/2021
- Last edited
- 17/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
This study aims to identify genetic predisposition to specific syndromes of critical illness. Specifically, susceptibility to life-threatening infections caused by an identified pathogen, and susceptibility to death following the onset of organ failure due to sepsis or sterile injury. In order to maximise the probability of identifying host genetic loci associated with susceptibility, we will restrict some analyses to younger individuals in good general health, and lacking in known predisposing factors.
The same principle was used to determine an upper age limit for inclusion for some analyses. With advancing age, there is an increase in undiagnosed comorbidity, frailty, and susceptibility to serious complications of infection or critical injury. There is therefore an increase in the probability of susceptibility to, and mortality from, critical illness that is consequent upon non-genetic factors.
Who can participate?
Prospective recruitment - Patients meeting the entry criteria (5.5) will be asked to provide informed consent, and a single DNA sample.
Recruitment of survivors - The group of survivors eligible for recruitment for this study are generally healthy individuals who have suffered critical illness.
What does the study involve?
Informed consent, and a single DNA sample.
What are the possible benefits and risks of participating?
There are no potential benefits to an individual from participation. However, if successfully completed, this study may provide fundamental insights into the pathogenesis of critical illness in infectious diseases and may ultimately lead to the development of novel treatments that could prevent flu and other diseases.
Where is the study run from?
The University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
December 2014 to August 2029
Who is funding the study:
Sepsis Research (FEAT), Intensive Care Society, the Wellcome Trust, and the Medical Research Council (UK)
Who is the main contact:
Dr Kenneth Baillie,
Genomic.study@ed.ac.uk
Contact information
Scientific
Roslin Institute
University of Edinburgh
Easter Bush
Midlothian
Edinburgh
EH25 9RG
United Kingdom
0000-0001-5258-793X | |
Phone | +44 (0)300 365 7660 |
genomicc@roslin.ed.ac.uk |
Study information
Study design | Multi-centre prospective observational study |
---|---|
Primary study design | Observational |
Secondary study design | Case-control study |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Patient information material can be found at https://genomicc.org/investigators/protocol/uk/ |
Scientific title | Genetics Of susceptibility and Mortality In Critical Care (GenOMICC) |
Study acronym | GenOMICC |
Study hypothesis | What are the genes that cause some people to be susceptible to life-threatening infection, or death from critical illness? |
Ethics approval(s) | 1. Approved 08/12/2016, Scotland A REC (2nd Floor Waverley Gate, 2 - 4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44(0)131 465 5678; Manx.Neill@nhslothian.scot.nhs.uk), ref 15/SS/0180/AM01/1 2. Approved 10/10/2019, Health Research Authority (Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; hra.approval@nhs.net), ref: 19/WM/0247 |
Condition | Genetics of susceptibility and mortality in life-threatening infection |
Intervention | Current interventions as of 15/04/2024: People with severe illness (such as COVID-19, influenza, sepsis, and other causes of critical illness), and healthy volunteers (for comparison) will be approached to participate in the study. Participants will be asked to consent by signing a consent form. A single blood sample will be taken (roughly 4 ml) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred. Previous interventions: People with severe illness (such as COVID-19, influenza, sepsis, and other causes of critical illness), and healthy volunteers (for comparison) will be approached to participate in the study. Participants will be asked to consent by signing a consent form. A single blood sample will be taken (9 ml; roughly 2 teaspoons) to get a DNA sample. If a participant is unable to give a blood sample for any reason, a sample of saliva may be taken instead in some circumstances. For those participants who have been discharged from the hospital, a research nurse will arrange a home visit at a convenient time, or a saliva sample kit can be sent if preferred. |
Intervention type | Other |
Primary outcome measure | 60-day survival measured using electronic medical records post recruitment |
Secondary outcome measures | The genetic data from severely ill patients will be measured in comparison with the genetic data from volunteers who suffered only mild symptoms using whole genome sequencing and/or SNP arrays at one-time point to try to determine which genes might play a part in an illness progressing to critical illness |
Overall study start date | 01/12/2014 |
Overall study end date | 31/08/2029 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Mixed |
Sex | Both |
Target number of participants | 40,000 |
Participant inclusion criteria | 1. Patients will be recruited who: 1.1. Are deemed, in the view of the treating physician, to require continuous cardiovascular or respiratory monitoring or invasive mechanical ventilation, 1.2. AND provide appropriate consent or assent, 1.3. AND present with one of the following primary diagnoses: 2. Group 1: specific infectious syndromes in highly-selected patients 2.1. COVID-19. Confirmed or suspected COVID-19. 2.2. Influenza. Confirmed or suspected infection with influenza virus. 2.3. Secondary pneumonia. Acute pneumonia complicating confirmed infection with influenza virus. 2.4. Dengue. Confirmed or suspected infection with dengue virus. 2.5. RSV. Confirmed infection with respiratory syncytial virus. 2.6. Emerging infections. Confirmed or suspected infection with an emerging infection (see below). 3. Group 2: specific non-infectious critical illness syndromes: 3.1. Burns. Full-thickness burns covering > 20% of body surface area. 3.2. Emerging critical illness syndromes. Confirmed or suspected presence of an emerging critical illness syndrome. These are unexplained or idiosyncratic presentations of acute organ injury, or suspected reactions to therapeutic agents, including: 3.3. acute disease associated with inhalation of noxious substances or vapours, such as "vaping" 3.4. acute disease associated with CAR T-cell therapy 4. Group 3: extreme critical illness 4.1. Extra-corporeal life support. Requirement for continuous veno-venous extra-corporeal support for respiratory failure of any aetiology. 5. Group 4: common/nonspecific critical illness syndromes: 5.1. Cellulitis. Soft tissue infections causing systemic sepsis. 5.2. Pneumonia. Primary pneumonia of any aetiology, with radiographic changes at presentation to critical care. Pneumonia is defined as: symptoms and signs consistent with an acute lower respiratory tract infection associated with new radiographic shadowing for which there is no other explanation (eg, not pulmonary oedema or infarction). Where this illness is the primary reason for hospital admission and is managed as pneumonia, the patient is eligible for inclusion.(Harris et al, 2011). No microbiology information is required to meet this entry criterion. 5.3. Pancreatitis. Pancreatitis of any aetiology. 5.4. Emerging Infections Emerging infections are by their nature unpredictable and present a significant challenge to the international research community. In order to ensure research preparedness, in accordance with the principles laid out by the International Severe Acute and Emerging Infection Consortium (ISARIC)(Dunning et al. 2014), patients will be recruited to this study if they have confirmed or suspected infection with a novel pathogen, a new strain of an existing pathogen, or a re-emerging known pathogen, that causes life-threatening illness. This will include the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), highly pathogenic strains of influenza, Ebola virus disease and other epidemics of viral haemorrhagic fever. |
Participant exclusion criteria | Current participant exclusion criteria as of 25/01/2023: There are no exclusion criteria. All consenting patients can be recruited. Previous participant exclusion criteria: Exclusion criteria do not apply to COVID-19. All consenting COVID-19 patients will be included. For all inclusion categories apart from COVID-19, patients who are functionally limited by any comorbid illness (such as frailty, heart failure, chronic obstructive pulmonary disease (COPD), or reduced exercise tolerance of any cause) or have significant immunosuppression (such as cancer chemotherapy or acquired immune deficiency syndrome) will be excluded from this study. |
Recruitment start date | 01/01/2016 |
Recruitment end date | 31/08/2029 |
Locations
Countries of recruitment
- Canada
- England
- Ireland
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Edinburgh
EH16 4SA
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Howden
Livingston
EH54 6PP
United Kingdom
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Steeton
KEIGHLEY
BD20 6TD
United Kingdom
Liverpool
L12 2AP
United Kingdom
Newport
NP20 2UB
United Kingdom
CWNBRAN
NP44 2XJ
United Kingdom
CHERTSEY
KT16 0PZ
United Kingdom
Rom Valley Way
ROMFORD
RM7 0AG
United Kingdom
Gawber Road
BARNSLEY
S75 2EP
United Kingdom
London
E1 1BB
United Kingdom
Britannia Road
BEDFORD
MK42 9DJ
United Kingdom
Belfast
BT12 6BA
United Kingdom
Belfast
BT9 7AB
United Kingdom
London
EC1A 7BE
United Kingdom
London
E13 8SL
United Kingdom
London
E11 1NR
United Kingdom
London
E1 4DG
United Kingdom
BANGOR
LL57 2PW
United Kingdom
Denbighshire
LL18 5UJ
United Kingdom
WREXHAM
LL13 7TD
United Kingdom
BIRMINGHAM
B4 6NH
United Kingdom
Whinney Heys Road, Lancashire
BLACKPOOL
FY3 8NR
United Kingdom
Bolton
BL4 0JR
United Kingdom
BRADFORD
BD9 6R
United Kingdom
Haywards Heath
RH16 4EX
United Kingdom
Brighton
BN2 5BE
United Kingdom
Eastern Road
BRIGHTON
Brighton
BN2 5BE
United Kingdom
Mandeville Road
AYLESBURY
HP21 8AL
United Kingdom
HALIFAX
HX3 0PW
United Kingdom
Lindley
HUDDERSFIELD
HD3 3EA
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
CARDIFF
CF14 4XW
United Kingdom
London
SW10 9NH
United Kingdom
4thFloor, East wing
West Middlesex University Hospital
Twickenham Road
ISLEWORTH
TW7 6AF
United Kingdom
Chesterfield
S44 5BL
United Kingdom
Chester
CH2 1UL
United Kingdom
DURHAM
DH1 5TW
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Croydon
CR7 7YE
United Kingdom
Rhondda Cynon Taf
CF72 8XR
United Kingdom
MERTHYR TYDFIL
CF47 9DT
United Kingdom
BRIDGEND
CF31 1RQ
United Kingdom
Dartford
DA2 8DA
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
ASHFORD
TN24 0LZ
United Kingdom
KENT
Margate
CT9 4AN
United Kingdom
Kent
Kent
CT1 3NG
United Kingdom
Lancashire
Blackburn
BB2 3HH
United Kingdom
Essex
Colchester
CO4 5JR
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Frimley
Surrey
Camberley
GU16 7UJ
United Kingdom
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
London
WC1N 1EH
United Kingdom
Marlborough Road
Wiltshire
Swindon
SN3 6BB
United Kingdom
London
SE1 9RT
United Kingdom
London
SW3 6NP
United Kingdom
Winchester
SO22 5DG
United Kingdom
Hampshire
Basingstoke
RG24 9NA
United Kingdom
North Yorkshire
Harrogate
HG2 7SX
United Kingdom
London
E9 6SR
United Kingdom
Hull
HU3 2JZ
United Kingdom
Pembrokeshire
Haverfordwest
SA61 2PZ
United Kingdom
CARMARTHEN
SA31 2AF
United Kingdom
ABERYSTWYTH
SY23 1ER
United Kingdom
Llanelli
SA14 8QF
United Kingdom
London
W2 1NY
United Kingdom
London
W6 8RF
United Kingdom
London
W12 0HS
United Kingdom
Isle of Wight
Newport
PO30 5TG
United Kingdom
Gorleston-on-Sea
Norfolk
Great Yarmouth
NR31 6LA
United Kingdom
Kettering
Northants
NN16 8UZ
United Kingdom
London
Kings College Hospital, Denmark Hill, London, SE5 9RS
United Kingdom
Kingston Upon Thames
KT2 7QB
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
LEEDS
LS9 7TF
United Kingdom
Leeds
LS1 3EX
United Kingdom
Woolwich
SE18 4QH
United Kingdom
Lewisham
London
SE13 6LH
United Kingdom
Liverpool_Chest Upon Thames
Surrey
KT1 7QB
United Kingdom
Liverpool
L7 8XP
United Kingdom
Liverpool
L9 7AL
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Southall
UB1 3HW
United Kingdom
Maidstone
Kent
ME16 9QQ
United Kingdom
PEMBURY
TN2 4QJ
United Kingdom
Manchester
M13 9WL
United Kingdom
Manchester
M23 9QZ
United Kingdom
Oxford Road Campus
Manchester
M13 9WL
United Kingdom
Windmill Road
Gillingham
Kent
ME7 5NY
United Kingdom
Basildon
SS16 5NL
United Kingdom
WESTCLIFF-ON-SEA
SS0 0RY
United Kingdom
Chelmsford
CM1 7ET
United Kingdom
Aberford Road
Wakefield
WF1 4AL
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
KILMARNOCK
KA2 0BE
United Kingdom
AYR
KA6 6DX
United Kingdom
MELROSE
TD6 9BS
United Kingdom
DUMFRIES
DG2 8RX
United Kingdom
KIRKCALDY
KY2 5AH
United Kingdom
LARBERT
FK5 4WR
United Kingdom
Glasgow
G51 4TF
United Kingdom
Glasgow
G31 2ER
United Kingdom
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Paisley
PA2 9PN
United Kingdom
Inverness
IV2 3UJ
United Kingdom
East Kilbride
G75 8RG
United Kingdom
Wishaw
ML2 0DP
United Kingdom
AIRDRIE
ML6 0JS
United Kingdom
Clydebank
Glasgow
G81 4DY
United Kingdom
Norwich
NR4 7UY
United Kingdom
Bristol
BS10 5NB
United Kingdom
Carlisle
Cumbria
CA2 7HY
United Kingdom
Whitehaven
CUMBRIA
CA28 8JG UK
United Kingdom
London
N18 1QX
United Kingdom
STOCKTON ON TEES
TS19 8PE
United Kingdom
HUNTINGDON
PE29 6NT
United Kingdom
PETERBOROUGH
PE3 9GZ
United Kingdom
NORTHAMPTON
NN1 5BD
United Kingdom
BARNSTAPLE
EX31 4JB
United Kingdom
Antrim
BT41 2RL
United Kingdom
GRIMSBY
DN33 2BA
United Kingdom
Scunthorpe
DN15 7BH
United Kingdom
North Shields
NE29 8NH
United Kingdom
Ashington
NE63 9JJ
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
NOTTINGHAM
NG7 2UH
United Kingdom
Headington
OXFORD
OX3 9DU
United Kingdom
CAMBRIDGE
CB2 0AY
United Kingdom
COSHAM
PO6 3LY
United Kingdom
East Grinstead
RH19 3DZ
United Kingdom
BERKSHIRE
Reading
RG1 5AN
United Kingdom
Truro
TR1 3LJ
United Kingdom
EXETER
EX2 5DW
United Kingdom
Hampstead
London
NW3 2QG
United Kingdom
BARNET
EN5 3DJ
United Kingdom
Guildford
GU2 7XX
United Kingdom
Bath
BA1 3NG
United Kingdom
Salford
MANCHESTER
M6 8HD
United Kingdom
SALISBURY
SP2 8BJ
United Kingdom
SHEFFIELD
S10 2TH
United Kingdom
SHEFFIELD
S10 2JF
United Kingdom
Sheffield
S5 7AU
United Kingdom
SUTTON-IN-ASHFIELD
NG17 4JL
United Kingdom
Shrewsbury
SHROPSHIRE
SY3 8XQ
United Kingdom
Apley
TELFORD
TF1 6TF
United Kingdom
Taunton
SOMERSET
C Shovelton/ P Doble, Critical Care Research Nurses Old Building, generic office, Vascular dept Somerset NHS Foundation Trust Musgrove Park Hospital, Parkfield Drive, Taunton SOMERSET TA1 5DA
United Kingdom
Middlesbrough
CLEVELAND
TS4 3BW
United Kingdom
SUNDERLAND
SR4 7TP
United Kingdom
Warwick
CV34 5BW
United Kingdom
PORTADOWN
BT63 5QQ
United Kingdom
Town lane
Kew
SOUTHPORT
PR8 6PN
United Kingdom
TOOTING
London
SW17 0QT
United Kingdom
Prescot
L35 5DR
United Kingdom
Poplar Grove, Hazel Grove
STOCKPORT
SK2 7JE
United Kingdom
REDHILL
RH1 5RH
United Kingdom
MORRISTON
SWANSEA
SA6 6NL
United Kingdom
ASHTON-UNDER-LYNE
OL6 9R
United Kingdom
DUNDEE
DD1 9SY
United Kingdom
Manchester
M20 4BX
United Kingdom
Dudley
DY1 2HQ
United Kingdom
NEWCASTLE UPON TYNE
NE1 4LP
United Kingdom
BURY
BL9 7TD
United Kingdom
OLDHAM
OL1 2JH
United Kingdom
Crumpsall
MANCHESTER
M8 5RB
United Kingdom
Harlow
ESSEX
CM20 1QX
United Kingdom
KING’S LYNN
PE30 4ET
United Kingdom
ROTHERHAM
S60 2UD
United Kingdom
LONDON
SW3 6JJ
United Kingdom
The Chesnuts
WOLVERHAMPTON
WV10 0QP
United Kingdom
TORQUAY
TQ2 7AA
United Kingdom
LINCOLN
LN2 5QY
United Kingdom
BOSTON
PE21 9QS
United Kingdom
LONDON
NW1 2BU
United Kingdom
LONDON
WC1N 3BG
United Kingdom
DERBY
DE22 3NE
United Kingdom
Burton Upon Trent
STAFFORDSHIRE
DE13 0RB
United Kingdom
Southampton
HAMPSHIRE
SO16 6YD
United Kingdom
Edgbaston
BIRMINGHAM
B15 2TH
United Kingdom
BIRMINGHAM
B9 5SS
United Kingdom
SUTTON
COLDFIELD
B75 7RR
United Kingdom
BRISTOL
BS2 8HW
United Kingdom
COVENTRY
CV2 2DX
United Kingdom
BOURNEMOUTH
BH7 7DW
United Kingdom
POOLE
BH15 2JB
United Kingdom
LEICESTER
LE1 5WW
United Kingdom
Leicester
LE3 9QP
United Kingdom
Infirmary Square
LEICESTER
LE1 5WW
United Kingdom
LANCASTER
LA1 1RP
United Kingdom
BARROW IN FURNESS
LA14 4LF
United Kingdom
Stoke-on-Trent
STAFFORDSHIRE
ST4 6QG
United Kingdom
PLYMOUTH
PL6 5FP
United Kingdom
WALSALL
WS2 9PS
United Kingdom
WARRINGTON
WA5 1QG
United Kingdom
WATFORD
WD18 0HB
United Kingdom
Bury St Edmunds
SUFFOLK
IP33 2QZ
United Kingdom
WORTHING
BN11 2DH
United Kingdom
CHICHESTER
PO19 6SE
United Kingdom
LONDON
N19 5NF
United Kingdom
UPTON
BIRKENHEAD
CH49 5PE
United Kingdom
REDDITCH
B98 7UB
United Kingdom
Worcester
WR5 1DD
United Kingdom
Wigan Lane
WIGAN
WN1 2NN
United Kingdom
HEREFORD
HR1 2ER
United Kingdom
YEOVIL
BA21 4AT
United Kingdom
YORK
YO31 8HE
United Kingdom
SCARBOROUGH
YO12 6QL
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Bristol
BS2 8BJ
United Kingdom
Antrim
BT41 2RL
United Kingdom
Londonderry
BT47 6SB
United Kingdom
London
SW3 6NP
United Kingdom
Smethwick
B66 2QT
United Kingdom
Sponsor information
Research organisation
47 Little France Cres
Edinburgh
EH16 4TJ
United Kingdom
Phone | +44 (0)131 242 3330 |
---|---|
ACCORD@nhslothian.scot.nhs.uk | |
Website | http://accord.scot/ |
https://ror.org/01x6s1m65 |
Funders
Funder type
Charity
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | 31/08/2030 |
---|---|
Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Stored in publicly available repository |
Publication and dissemination plan | Peer-reviewed scientific journals, internal report, conference presentation, publication on website |
IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (genomicc.org/data). Type of data that will be shared: summary statistics for GWAS data When the data will become available and for how long: data will be available as soon as the analysis is completed to a satisfactory standard and will be maintained indefinitely. By what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism: Summary data will be publicly available to the public when the analysis has been completed to a satisfactory standard. Prior to the completion of the analysis, the summary statistics, or intermediate files may be made available to collaborators to assist with other analysis plans Whether consent from participants was obtained: consent has been obtained. The data to be shared openly is summary data and does not contain any identifiable information or data relating to individual genomes Comments on data anonymisation, any ethical or legal restrictions, any other comments: The summary data/summary statistics do not contain data relating to individual genomes or identifiable information. The exported data are summary statistics that do not contain individual information about individuals. The researchers are using variants with a minor allele frequency (MAF) of 1% which avoids identification of individuals using genetic data (because at least 1% of the population will have the minor allele of the variant which is enough people to be impossible to identify). |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Preprint results | 08/05/2021 | 01/06/2021 | No | No | |
Preprint results | 08/03/2021 | 01/06/2021 | No | No | |
Preprint results | 22/04/2021 | 01/06/2021 | No | No | |
Results article | genome-wide association study results | 04/03/2021 | 01/06/2021 | Yes | No |
Results article | Critical COVID-19 results | 07/03/2022 | 31/03/2022 | Yes | No |
Results article | 17/05/2023 | 25/05/2023 | Yes | No | |
HRA research summary | 28/06/2023 | No | No | ||
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/01/2025: The study participating centres City Hospital, Sandwell General Hospital were removed and Midland Metropolitan University Hospital was added.
15/04/2024: The following updates were made:
1. Interventions were changed.
2. The Royal Brompton Hospital was added as a study participating centre.
30/01/2024: The study participating centres were updated to remove Mater Hospital, Barts-Nightingale, Doncaster & Bassetlaw Hospitals NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Freeman Hospital, The Walton Centre NHS Foundation Trust, and Royal National Orthopaedic Hospital; and add Bristol Royal Hospital for Children, Antrim Area Hospital and Altnagelvin Hospital.
11/10/2023: The study participating centres were updated to remove Mid Cheshire Hospitals NHS Foundation Trust and add Ulster Hospital.
25/05/2023: Publication reference added.
25/01/2023: The following changes have been made:
1. Study design was changed from "Multicentre prospective and retrospective interventional non-randomized study" to "Multi-centre prospective observational study".
2. Primary study design was changed from "interventional" to "observational".
3. Secondary study design was changed from "non-randomised study" to "case-control study".
4. Intervention type was changed from "Genetic" to "Other".
5. Primary outcome measure was changed from "Mortality measured through electronic medical records at 60 days from the first time the patient met the medical criteria" to "60-day survival measured using electronic medical records post recruitment"
6. Secondary outcome measure was changed from "Genetic data will be measured by Whole Genome Sequencing and/or SNP arrays depending on availability, background ethnicity of samples and technology at the time of sequencing. Measurement will be of the differences in allele frequency between cases (ICU patients, defined in protocol) and controls (matched controls, without severe phenotype)." to "The genetic data from severely ill patients will be measured in comparison with the genetic data from volunteers who suffered only mild symptoms using whole genome sequencing and/or SNP arrays at one time point to try to determine which genes might play a part in an illness progressing to critical illness".
7. Participant information sheet link was updated.
03/11/2022: Leighton Hospital was added as a trial participating centre.
30/06/2022: Mid Cheshire Hospitals NHS Foundation Trust was added as a trial participating centre. PubMed addresses added for publications.
8. Recruitment start date was changed from 04/07/2019 to 01/01/2016.
31/03/2022: Publication reference added.
09/06/2021: Trial's existence confirmed by Scotland A REC.