Sepsis Clinical Trial
— ORPICUOfficial title:
Oxidative Monitoring in ICU Patients.
Verified date | April 2014 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Observational |
Sepsis is common in the ICU and is associated with high mortality that reaches up to 60%,
increased duration of hospitalization and additional costs [1,2].Early diagnosis and
stratification of severity are of great importance in order to timely apply proper and
adequate treatment [3].
Oxidative stress is implicated in inflammation and sepsis and sepsis severity seems to
correlate with increased oxidative stress [7,8]. Monitoring of oxidative stress has been
done so far with various markers which reflect the different pathways of oxidative stress as
is oxidosis of lipids, proteins, nucleic acids; yet the antioxidant capacity of various
enzymes and vitamins has been studied [9]. However these methods do not reflect oxidative
stress as a whole, are time consuming, need special laboratory procedures and are costly.
Oxidation-reduction potential is a new technique that enables bedside assessment of the
oxidative status. It is based on measuring the balance of oxidants and reductants in human
blood with a simple plasma test that reports results immediately.
Hypothesis
Oxidation-reduction potential, used for oxidative monitoring in ICU patients, might
correlate with sepsis severity and may be used in addition to other clinical and/or
inflammatory markers to assess severity and possibly prognosis.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 2016 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - All subjects entering to the ICU and are expected to stay for more than 72 hours are eligible to participate. Sepsis is recognized, defined and categorized according to the Surviving Sepsis Campaign criteria [10]. Exclusion Criteria: i) patients who receive chronic renal replacement therapy, iii) age under 18, iv) patients with body mass index<18, v) antioxidant supplementation two weeks prior to ICU admission |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | ICU, University Hospital of Larissa | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sepsis severity | Time of sepsis diagnosis | No | |
Secondary | mortality | 28th day | No | |
Secondary | ICU outcome | within 28 days | No |
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