The Utility of Ischemia Modified Albumin (IMA) in Sepsis

• ClinicalTrials.gov Identifier: NCT00448968
• Recruitment Status: Completed
• First Posted: March 19, 2007
• Last Update Posted: September 27, 2007
• Sponsor: Inverness Medical Innovations
• Information provided by: Inverness Medical Innovations

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

Eligibility Criteria

• 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

Contacts and Locations

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.; The Cleveland Clinic

More Information

• ClinicalTrials.gov Identifier: NCT00448968
• Other Study ID Numbers: IMA-0806-003
• First Posted: March 19, 2007
• 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:

Sepsis; Toxemia; Syndrome; Ischemia; Systemic Inflammatory Response Syndrome; Disease; Pathologic Processes; Infection; Inflammation; Shock