Study 1 of 320 for search of: "Sepsis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Utility of Ischemia Modified Albumin (IMA) in Sepsis
This study has been completed.
Sponsored by: Inverness Medical Innovations
Information provided by: Inverness Medical Innovations
ClinicalTrials.gov Identifier: NCT00448968
  Purpose

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
Sepsis
Severe Sepsis
Systemic Inflammatory Response Syndrome
Sepsis Syndrome

MedlinePlus related topics: Sepsis
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title: The Utility of Ischemia Modified Albumin (IMA) in Sepsis

Further study details as provided by Inverness Medical Innovations:

Enrollment: 150
Study Start Date: March 2007
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448968

Locations
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
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. Cleveland Clinic
  More Information

Study ID Numbers: IMA-0806-003
Study First Received: March 16, 2007
Last Updated: September 26, 2007
ClinicalTrials.gov Identifier: NCT00448968  
Health Authority: United States: Institutional Review Board

Keywords provided by Inverness Medical Innovations:
Sepsis
Ischemia Modified Albumin
Systemic Inflammatory Response Syndrome

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Ischemia
Inflammation

Additional relevant MeSH terms:
Disease
Pathologic Processes
Syndrome
Infection

ClinicalTrials.gov processed this record on January 16, 2009