Clinical trial NCT00448968: The Utility of Ischemia Modified Albumin (IMA) in Sepsis
Official title: The Utility of Ischemia Modified Albumin (IMA) in Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Severe Sepsis
Systemic Inflammatory Response Syndrome
Sepsis Syndrome
Keywords: Sepsis
Ischemia Modified Albumin
Systemic Inflammatory Response Syndrome
Lead sponsor: Inverness Medical Innovations
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinc
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Nathan Shapiro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Munish Goyal, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Rakesh Engineer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: