The Utility of Ischemia Modified Albumin (IMA) in Sepsis

Sepsis Clinical Trial

Official title:

The Utility of Ischemia Modified Albumin (IMA) in Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448968
• Other study ID #: IMA-0806-003
• 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
• 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

• Sepsis
• Sepsis Syndrome
• Severe Sepsis
• Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

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,