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The Utility of Ischemia Modified Albumin (IMA) in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00448968
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : September 27, 2007
Sponsor:
Information provided by:
Inverness Medical Innovations

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.


Condition or disease
Sepsis Severe Sepsis Systemic Inflammatory Response Syndrome Sepsis Syndrome

Detailed 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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Defined Population
Time Perspective: Other
Official Title: The Utility of Ischemia Modified Albumin (IMA) in Sepsis
Study Start Date : March 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinc
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inverness Medical Innovations
Investigators
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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
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ClinicalTrials.gov Identifier: NCT00448968    
Other Study ID Numbers: IMA-0806-003
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: September 2007
Keywords provided by Inverness Medical Innovations:
Sepsis
Ischemia Modified Albumin
Systemic Inflammatory Response Syndrome
Additional relevant MeSH terms:
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Sepsis
Toxemia
Syndrome
Ischemia
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Infection
Inflammation
Shock