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| Sponsors and Collaborators: |
University of Oxford Sainsbury Family Charitable Trusts Wellcome Trust Centre for Human Genetics, Oxford Queen Mary University of London William Harvey Research Institute, London |
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| Information provided by: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00131196 |
Purpose
The proposal is aimed at identifying genetic factors that determine the incidence and severity of, and the outcome from life−threatening infections (severe sepsis/septic shock) in patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with pneumonia which developed outside the hospital (community acquired pneumonia − CAP) or contamination of the abdominal cavity with faeces due to a leak in the bowel (faecal peritonitis). This will require the acquisition of a large, high quality resource of genetic material (DNA), plasma, urine, white blood cells and clinical information from well characterised groups of similar patients with, or at risk for, severe sepsis/septic shock. The principal objective is to perform studies which are sufficiently large to establish beyond doubt the influence of a series of selected "candidate" genes on the development, progress and outcome of sepsis.
| Condition |
|---|
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Pneumonia Peritonitis |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Functional Genomic Influences on Disease Progression and Outcome in Sepsis Due to Pneumonia or Peritonitis |
| Estimated Enrollment: | 7000 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2008 |
The investigators plan to recruit 5,000 cases of community acquired pneumonia (CAP) and 2,000 cases of faecal peritonitis (FP) from 30 UK ICUs and HDUs (members of the UK Critical Care Genomics group − UKCCG). The large number of patients is required to satisfy the power calculations based upon the predicted allele frequencies of candidate genes and the level of functional expression of the gene polymorphisms.
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 characterised 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). 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 metabonomic 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 co−ordinator, where they will be archived. The data will be entered independently by the research co−ordinator 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Charles J Hinds, MD | +44 02076017525 | c.j.hinds@qmul.ac.uk |
| Contact: Christopher S Garrard, MD PhD | +44 1865 767250 | chris.garrard@ndm.ox.ac.uk |
Show 30 Study Locations| Principal Investigator: | Christopher S Garrard, MD PhD | University of Oxford, UK |
| Principal Investigator: | Charles J Hinds, MD | Queen Mary College, University of London, UK |
| Principal Investigator: | Simon Baudouin, MD | Royal Victoria Infirmary, Newcastle, UK. |
| Principal Investigator: | David Higgins, MD | Southend General Hospital, Southend, UK. |
| Principal Investigator: | John Bleasdale, MD | City Hospital, Birmingham, UK. |
| Principal Investigator: | Richard Venn, MD | Worthing and Southlands Hospitals NHS Trust, Worthing, UK. |
| Principal Investigator: | Robert Ghosh, MD | Homerton Hospital, London, UK. |
| Principal Investigator: | Atul Kapila, MD | Royal Berkshire Hospital, Reading, UK. |
| Principal Investigator: | Simon Fletcher, MD | Norfolk and Norwich University Hospitals, Norwich, UK. |
| Principal Investigator: | Tim Gould, MD | Bristol Royal Infirmary, Bristol, UK. |
| Principal Investigator: | Philip Young, MD | Queen Alexandra hospital, Portsmouth, UK. |
| Principal Investigator: | Rob Loveland, MD | Wexham Park Hospital |
| Principal Investigator: | Brian Sweeney, MD | Poole Hospital, Poole, UK. |
| Principal Investigator: | Colin Ferguson, MD | Derriford Hospital, Plymouth, UK. |
| Principal Investigator: | Ian Mackenzie, MD | Addenbrooke's Hospital, Cambridge, UK. |
| Principal Investigator: | Julian Bion, MD | Queen Elizabeth Hospital, Birmingham, UK. |
| Principal Investigator: | Peter Nightingale, MD | Withington Hospital, Manchester, UK. |
| Principal Investigator: | Gary Mills, MD | Royal Halamshire Hospital, Sheffield, UK. |
| Principal Investigator: | Stephen Bonner, MD | James Cook University Hospital, Middlesborough, UK. |
| Principal Investigator: | Mark Garfield, MD | The Ipswich Hospital, Ipswich, UK. |
| Principal Investigator: | Grahame Sanders, MD | Medway Maritime Hospital, Gillingham, UK. |
| Principal Investigator: | Ronald Baillie, MD | Antrim Hospital, Antrim, Northern Ireland. |
| Principal Investigator: | George Findlay, MD | University Hospital of Wales, Cardiff,UK. |
| Principal Investigator: | John Pappachan, MD | Southampton General Hospital, Southampton, UK. |
| Principal Investigator: | Geoffrey Bellingan, MD | UCLH Middlesex Hospital, London, UK. |
| Principal Investigator: | Mark Palazzo, MD | Charing Cross Hospital, London, UK. |
| Principal Investigator: | Neil Soni, MD | Chelsea and Westminster Hospital, London, UK. |
| Principal Investigator: | Alastair Short, MD | Broomfield Hospital, Chelmsford, UK. |
| Principal Investigator: | Gary Brear, MD | Wythenshawe Hospital, Manchester, UK. |
| Principal Investigator: | Roop Kishen, MD | Hope Hospital, Manchester, UK. |
More Information
| Study ID Numbers: | N8518 |
| Study First Received: | August 15, 2005 |
| Last Updated: | January 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00131196 |
| Health Authority: | United Kingdom: National Health Service |
|
pneumonia peritonitis sepsis outcome genomics |
|
Sepsis Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Peritonitis Peritoneal Diseases Disease Progression Pneumonia |
|
Disease Attributes Pathologic Processes |
