Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131196
Status:
UNKNOWN
Last Update Posted:
2016-05-16
First Post:
2005-08-15
Brief Title:
Functional Genomic Influences on Disease Progression and Outcome in Sepsis
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Functional Genomic Influences on Disease Progression and Outcome in Sepsis Due to Pneumonia or Peritonitis
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAinS
Brief Summary:
The proposal is aimed at identifying genetic factors that determine the incidence and severity of and the outcome from life-threatening infections severe sepsisseptic 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 characterized groups of similar patients with or at risk for severe sepsisseptic 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
Detailed Description:
The investigators plan to recruit 2000 cases of community acquired pneumonia CAP and 2000 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 patients 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
If a patient is eligible written informed consent will be obtained either from the patient or if the patient is incompetent via the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None