Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448968
Status:
COMPLETED
Last Update Posted:
2007-09-27
First Post:
2007-03-16
Brief Title:
The Utility of Ischemia Modified Albumin IMA in Sepsis
Sponsor:
Inverness Medical Innovations
Organization:
Inverness Medical Innovations
Study Overview
Official Title:
The Utility of Ischemia Modified Albumin IMA in Sepsis
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to determine if levels of ischemia modified albumin IMA in blood are elevated in patients with suspected infection and are predictive of severity of illness in patients with sepsis
In order to compare subjects with infection to those without infection who are representative of the ED population at each site a group of non-infected control patients will be enrolled Each hospital will enroll subjects with age by decade and sex matched controls to reflect the population of subjects suspected of infection
In order to compare subjects with infection to those without infection who are representative of the ED population at each site a group of non-infected control patients will be enrolled Each hospital will enroll subjects with age by decade and sex matched controls to reflect the population of subjects suspected of infection
Detailed Description:
Sepsis is an unconquered challenge in medicine affecting people of all ages and demographics Severe sepsis affects approximately 751000 patients in the United States per annum with healthcare costs approaching 167 billion dollars a year Mortality from severe sepsis and septic shock approaches 30 - 70 with 215000 deaths annually Thus sepsis is a disease with healthcare dollars and mortality rates approaching those of heart disease and cancer
Identifying patients with sepsis and in particular hypoperfusion is a challenge to the clinician A variety of clinical and laboratory findings are helpful but there is no single test to identify sepsis or assess its severity
Ischemia and reactive oxygen species play a significant role in the pathogenesis of sepsis Moreover there is evidence to suggest that septic shock results in dysfunction of autoregulatory mechanisms and misdistribution of blood flow precipitating both regional and global ischemia A method that can help rapidly assess hypoperfusion would be clinically useful Ischemia modified albumin IMA is a potential marker for ischemia in acute coronary syndrome patients thus it is hypothesized that IMA may be also useful as a prognostic biomarker for clinical identification of infection and the severity of illness in patients with sepsis
Identifying patients with sepsis and in particular hypoperfusion is a challenge to the clinician A variety of clinical and laboratory findings are helpful but there is no single test to identify sepsis or assess its severity
Ischemia and reactive oxygen species play a significant role in the pathogenesis of sepsis Moreover there is evidence to suggest that septic shock results in dysfunction of autoregulatory mechanisms and misdistribution of blood flow precipitating both regional and global ischemia A method that can help rapidly assess hypoperfusion would be clinically useful Ischemia modified albumin IMA is a potential marker for ischemia in acute coronary syndrome patients thus it is hypothesized that IMA may be also useful as a prognostic biomarker for clinical identification of infection and the severity of illness in patients with sepsis
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