The Utility of Ischemia Modified Albumin (IMA) in Sepsis
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|ClinicalTrials.gov Identifier: NCT00448968|
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : September 27, 2007
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.
|Condition or disease|
|Sepsis Severe Sepsis Systemic Inflammatory Response Syndrome Sepsis Syndrome|
Sepsis is an unconquered challenge in medicine, affecting people of all ages and demographics. Severe sepsis affects approximately 751,000 patients in the United States per annum, with healthcare costs approaching $16.7 billion dollars a year. Mortality from severe sepsis and septic shock approaches 30 - 70 % with 215,000 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.
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Observational Model:||Defined Population|
|Official Title:||The Utility of Ischemia Modified Albumin (IMA) in Sepsis|
|Study Start Date :||March 2007|
|Actual Study Completion Date :||September 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448968
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Nathan Shapiro, M.D.||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Munish Goyal, M.D.||University of Pennsylvania|
|Principal Investigator:||Rakesh Engineer, M.D.||The Cleveland Clinic|