Skip to main content
OpenTrials
Completed

NCT Number: NCT00448968

The Utility of Ischemia Modified Albumin (IMA) in Sepsis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Inverness Medical Innovations

Industry

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Mar 19, 2007
Registry last updated
Sep 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.