SepsisNCT00448968
The Utility of Ischemia Modified Albumin (IMA) in Sepsis
An observational study of Sepsis and Severe Sepsis, run by Inverness Medical Innovations at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Severe Sepsis, Systemic Inflammatory Response Syndrome
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Able to provide informed consent
- Clinical suspicion of infection
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cleveland Clinc
Cleveland, Ohio, 44195
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Keywords
- Sepsis, Ischemia Modified Albumin, Systemic Inflammatory Response Syndrome
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inverness Medical Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathan Shapiro, M.D., Principal investigator, Beth Israel Deaconess Medical CenterMunish Goyal, M.D., Principal investigator, University of PennsylvaniaRakesh Engineer, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448968
- Sponsor's protocol ID
- IMA-0806-003
- Status last verified
- Sep 2007
- First submitted
- 16 Mar 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Ischemia Modified Albumin (IMA) in Sepsis
- ClinicalTrials.gov ID
- NCT00448968
- Acronym / sponsor ID
- IMA-0806-003
- Keywords
- Sepsis, Ischemia Modified Albumin, Systemic Inflammatory Response Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Inverness Medical InnovationsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Able to provide informed consent
- Clinical suspicion of infection
- 18 years of age or older
- Emergency Department presentation as a result of a non-infectious etiology as determined by the treating clinicians
Key exclusion criteria (13 listed)
- Active chest pain of suspected cardiac origin
- ST elevation myocardial infarction or dynamic ST changes on EKG
- Pregnant women
- Cocaine use
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Shapiro, M.D. principal investigator
Beth Israel Deaconess Medical Center
Munish Goyal, M.D. principal investigator
University of Pennsylvania
Rakesh Engineer, M.D. principal investigator
The Cleveland Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Severe Sepsis, run by Inverness Medical Innovations at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2007.