Functional Genomic Influences on Disease Progression and Outcome in Sepsis
NCT ID: NCT00131196
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4000 participants
OBSERVATIONAL
2005-09-30
2017-12-31
Brief Summary
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Detailed Description
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If a patient is eligible, written, informed consent will be obtained either from the patient or, if the patient is incompetent via the patient's legal representative. Patients will be characterized clinically in terms of admission diagnosis, severity of illness (APACHE II), organ failures (SOFA) and final outcome (ICU and hospital mortality, death or survival 6 months following ICU admission. Date of death will be recorded when appropriate). Clinical status will be assessed daily for days 1, 2, 3, 5 and 7 of ICU admission using the Sepsis criteria, SOFA score, microbiological culture results and antibiotic therapy.
Selected ICUs will, following consent, also undertake blood and urine sampling on days 1, 3 and 5 for genomic, proteomic and metabolomic studies. Information will be recorded on a bar-coded paper clinical report form (CRF) at the bedside. The CRFs will be securely stored locally and copied to the research coordinator, where they will be archived. The data will be entered independently by the research coordinator and one of the investigators into a secure, central web-based electronic database for storage of clinical data and the calculation of derived values. The patient codes for genetic analysis will be derived directly from the clinical database. Those undertaking genotyping will be blinded to the clinical details and these two databases will be brought together at the time of analysis only under the direct supervision of one of the principal investigators.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Male or female of 18 years or more
* Patient admitted to ICU/HDU with faecal peritonitis or community acquired pneumonia
Exclusion Criteria
* Patient is under the age of 18 years
* Patient is already enrolled in an interventional study
* Patient is immunocompromised
* Patient is pregnant
* There is an advance directive to withhold or withdraw life-sustaining treatment or patient is admitted for palliative care only.
18 Years
ALL
No
Sponsors
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Sainsbury Family Charitable Trusts
OTHER
Wellcome Trust
OTHER
Queen Mary University of London
OTHER
Barts and the London School of Medicine and Dentistry
OTHER
University of Oxford
OTHER
Responsible Party
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Dr CS Garrard
Consultant in Intensive care
Principal Investigators
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Christopher S Garrard, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford, UK
Charles J Hinds, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary College, University of London, UK
Simon Baudouin, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Victoria Infirmary and Freeman Hospital, Newcastle, UK
David Higgins, MD
Role: PRINCIPAL_INVESTIGATOR
Southend General Hospital, Southend, UK.
Richard Venn, MD
Role: PRINCIPAL_INVESTIGATOR
Worthing and Southlands Hospitals NHS Trust, Worthing, UK.
David Watson, MD
Role: PRINCIPAL_INVESTIGATOR
Homerton University Hospital, London, UK.
Atul Kapila, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Berkshire Hospital, Reading, UK.
Simon Fletcher, MD
Role: PRINCIPAL_INVESTIGATOR
Norfolk and Norwich University Hospitals, Norwich, UK.
Andrew Johnston, MD
Role: PRINCIPAL_INVESTIGATOR
Addenbrooke's Hospital, Cambridge, UK.
Julian Bion, Professor
Role: PRINCIPAL_INVESTIGATOR
Queen Elizabeth Hospital, Birmingham, UK.
Gary Mills, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Halamshire Hospital, Sheffield, UK.
Stephen Bonner, MD
Role: PRINCIPAL_INVESTIGATOR
James Cook University Hospital, Middlesborough, UK.
Mark Garfield, MD
Role: PRINCIPAL_INVESTIGATOR
The Ipswich Hospital, Ipswich, UK.
Ronald Baillie, MD
Role: PRINCIPAL_INVESTIGATOR
Antrim Hospital, Antrim, Northern Ireland.
George Findlay, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Wales, Cardiff,UK.
Geoffrey Bellingan, MD
Role: PRINCIPAL_INVESTIGATOR
UCLH Middlesex Hospital, London, UK.
Tony Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
Charing Cross Hospital, London, UK.
Michelle Hayes, MD
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster Hospital, London, UK.
Dilshan Arawwawala, MD
Role: PRINCIPAL_INVESTIGATOR
Broomfield Hospital, Chelmsford, UK.
Andrew Bentley, MD
Role: PRINCIPAL_INVESTIGATOR
Wythenshawe Hospital, Manchester, UK.
Gareth Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
Hope Hospital, Manchester, UK.
Julian Knight, MD
Role: PRINCIPAL_INVESTIGATOR
Wellcome Trust
Jonathan Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals, Leicester
Jasmeet Soar, MD
Role: PRINCIPAL_INVESTIGATOR
Frenchay Hospital and Southmead Hospital, Bristol
Phil Watt, MD
Role: PRINCIPAL_INVESTIGATOR
Kettering General Hospital
Anton Krige, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Blackburn Hospital
Ian Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Castle Hill Hospital and Hull Royal Infirmary
Achyut Guleri, MD
Role: PRINCIPAL_INVESTIGATOR
Blackpool Victoria Hospital
Shond Laha, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Preston Hospital
Stephen Brett, MD
Role: PRINCIPAL_INVESTIGATOR
Hammersmith Hospitals NHS Trust
Jeronimo Moreno Cuesta, MD
Role: PRINCIPAL_INVESTIGATOR
North Middlesex University Hospital
Pyda Venkatesh, MD
Role: PRINCIPAL_INVESTIGATOR
Coventry University Hospital
Peter Hall, MD
Role: PRINCIPAL_INVESTIGATOR
Huddersfield Royal Infirmary and Calderdale Royal Hospital
Martin Kuper, MD
Role: PRINCIPAL_INVESTIGATOR
The WhittingtonHospital, London. UK
Sia Pesian, MD
Role: PRINCIPAL_INVESTIGATOR
Manor Hospital, Walsall. UK
Andrew Timmins, MD
Role: PRINCIPAL_INVESTIGATOR
Colchester Hospital, Colchester . UK
Stephen Drage, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Sussex County Hospital
Martin Stotz, MD
Role: PRINCIPAL_INVESTIGATOR
St. Mary's Hospital, London, UK
Mark Blunt, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Elizabeth Hospital, King's Lynn. UK
Nigel Webster, Professor
Role: PRINCIPAL_INVESTIGATOR
Aberdeen Royal Infirmary
Jane Minton, MD
Role: PRINCIPAL_INVESTIGATOR
St James Hospital, Leeds. UK
Matt Oram, MD
Role: PRINCIPAL_INVESTIGATOR
Cheltenham General Hospital, Cheltenham. UK
Ingrid Krupe, MD
Role: PRINCIPAL_INVESTIGATOR
Lewisham Hospital
Abhiram Mallick, MD
Role: PRINCIPAL_INVESTIGATOR
Leeds General Infirmary, Leeds. UK
Samuel Pambakian, MD
Role: PRINCIPAL_INVESTIGATOR
Frimley Park Hospital, Frimley. UK
Malcolm Watters, MD
Role: PRINCIPAL_INVESTIGATOR
Great Western Hospital, Swindon. UK
Locations
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Southmead Hospital
Bristol, Avon, United Kingdom
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
James Cook University Hospital
Middlesbrough, Cleveland, United Kingdom
Antrim Hospital
Antrim, County Antrim, United Kingdom
Castle Hill Hospital
Cottingham, East Riding of Yorkshire, United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Colchester General Hospital
Colchester, Essex, United Kingdom
Southend General Hospital
Southend, Essex, United Kingdom
Bristol Royal Infirmary
Bristol, Gloucestershire, United Kingdom
Cheltenham General Hospital
Cheltenham, Gloucestershire, United Kingdom
Withington Hospital
Manchester, Greater Manchester, United Kingdom
Wythenshawe Hospital
Manchester, Greater Manchester, United Kingdom
Hope Hospital
Manchester, Greater Manchester, United Kingdom
Royal Blackburn Hospital
Blackburn, Lancashire, United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom
Royal Preston Hospital
Preston, Lancashire, United Kingdom
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
University Hospital Lewisham
Lewisham, London, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, Norfolk, United Kingdom
Norfolk and Norwich University Hospitals
Norwich, Norfolk, United Kingdom
Kettering General Hospital
Kettering, Northants, United Kingdom
John Radcliffe Hospital
Oxford, Oxon, United Kingdom
University Hospital of Wales
Cardiff, South Glamorgan, United Kingdom
Frenchay Hospital
Bristol, South Gloucestershire, United Kingdom
The Ipswich Hospital
Ipswich, Suffolk, United Kingdom
Frimley Park Hospital
Frimley, Surrey, United Kingdom
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom
University Hospital
Coventry, Warwickshire, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Walsall Manor Hospital
Walsall, West Midlands, United Kingdom
Worthing and Southlands Hospitals NHS Trust
Worthing, West Sussex, United Kingdom
Calderdale Royal Hospital
Halifax, West Yorkshire, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Hull Royal Infirmary
Hull, Yorkshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Homerton Hospital
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
North Middlesex University Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
UCLH Middlesex Hospital
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Royal Halamshire Hospital
Sheffield, , United Kingdom
The Great Western Hospital
Swindon, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Vincent JL, Angus D, Annane D, Bernard G, Faist E, Giroir B, Reinhart K. Clinical expert round table discussion (session 5) at the Margaux Conference on Critical Illness: outcomes of clinical trials in sepsis: lessons learned. Crit Care Med. 2001 Jul;29(7 Suppl):S136-7. doi: 10.1097/00003246-200107001-00040. No abstract available.
Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.
File TM. Community-acquired pneumonia. Lancet. 2003 Dec 13;362(9400):1991-2001. doi: 10.1016/S0140-6736(03)15021-0.
Gordon AC, Lagan AL, Aganna E, Cheung L, Peters CJ, McDermott MF, Millo JL, Welsh KI, Holloway P, Hitman GA, Piper RD, Garrard CS, Hinds CJ. TNF and TNFR polymorphisms in severe sepsis and septic shock: a prospective multicentre study. Genes Immun. 2004 Dec;5(8):631-40. doi: 10.1038/sj.gene.6364136.
Mira JP, Cariou A, Grall F, Delclaux C, Losser MR, Heshmati F, Cheval C, Monchi M, Teboul JL, Riche F, Leleu G, Arbibe L, Mignon A, Delpech M, Dhainaut JF. Association of TNF2, a TNF-alpha promoter polymorphism, with septic shock susceptibility and mortality: a multicenter study. JAMA. 1999 Aug 11;282(6):561-8. doi: 10.1001/jama.282.6.561.
Sands KE, Bates DW, Lanken PN, Graman PS, Hibberd PL, Kahn KL, Parsonnet J, Panzer R, Orav EJ, Snydman DR, Black E, Schwartz JS, Moore R, Johnson BL Jr, Platt R; Academic Medical Center Consortium Sepsis Project Working Group. Epidemiology of sepsis syndrome in 8 academic medical centers. JAMA. 1997 Jul 16;278(3):234-40.
Sorensen TI, Nielsen GG, Andersen PK, Teasdale TW. Genetic and environmental influences on premature death in adult adoptees. N Engl J Med. 1988 Mar 24;318(12):727-32. doi: 10.1056/NEJM198803243181202.
Roy S, Knox K, Segal S, Griffiths D, Moore CE, Welsh KI, Smarason A, Day NP, McPheat WL, Crook DW, Hill AV; Oxford Pneumoccocal Surveillance Group. MBL genotype and risk of invasive pneumococcal disease: a case-control study. Lancet. 2002 May 4;359(9317):1569-73. doi: 10.1016/S0140-6736(02)08516-1.
Scicluna BP, Cano-Gamez K, Burnham KL, Davenport EE, Moore AR, Khan S, Hinds CJ, Cremer OL, Khatri P, Sweeney TE, Knight JC, van der Poll T. A consensus blood transcriptomic framework for sepsis. Nat Med. 2025 Sep 30. doi: 10.1038/s41591-025-03964-5. Online ahead of print.
Related Links
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GAinS Website (Genomic Advances in Sepsis)
Other Identifiers
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N8518
Identifier Type: -
Identifier Source: org_study_id
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