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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00448968
Other study ID # IMA-0806-003
Secondary ID
Status Completed
Phase N/A
First received March 16, 2007
Last updated September 26, 2007
Start date March 2007
Est. completion date September 2007

Study information

Verified date September 2007
Source Inverness Medical Innovations
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria for Sepsis Subjects:

- 18 years of age or older

- Able to provide informed consent

- Clinical suspicion of infection

Exclusion Criteria for Sepsis Subjects:

- Active chest pain of suspected cardiac origin

- ST elevation myocardial infarction or dynamic ST changes on EKG

- Pregnant women

- Cocaine use

- Liver disease

- Unable to speak or understand the English language

Inclusion Criteria for Control Subjects:

- 18 years of age or older

- Emergency Department presentation as a result of a non-infectious etiology as determined by the treating clinicians

- Able to provide informed consent

Exclusion Criteria for Control Subjects:

- Suspected Infection

- Temperature >100.4°F

- Pregnant women

- Possible cardiac, intestinal or cerebral ischemia

- Liver disease

- Any source of inflammation as part of their presentation

- cancer, any type

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Cleveland Clinc Cleveland Ohio
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Inverness Medical Innovations

Country where clinical trial is conducted

United States, 

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