The Utility of Ischemia Modified Albumin (IMA) in Sepsis

NCT00448968 | Completed

• 1 other identifier: IMA-0806-003
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Sepsis; Severe Sepsis; Systemic Inflammatory Response Syndrome; Sepsis Syndrome

Keywords

Sepsis; Ischemia Modified Albumin; Systemic Inflammatory Response Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to provide informed consent
• Clinical suspicion of infection

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Inverness Medical Innovations: lead

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinc

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 27, 2007

Record last verified: 2007-09

Locations

US (3)