Oxidative Monitoring in ICU Patients.

NCT02114853 | Unknown

• 1 other identifier: 4784.02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Sepsis severity

  Time of sepsis diagnosis

Secondary Outcomes (2)

• mortality

  28th day

• ICU outcome

  within 28 days

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects who enter to the intensive care unit are candidates for this protocol

You may qualify if:

• 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 \[10\].

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

ICU, University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Epaminondas Zakynthinos, Prof.

  University of Thessaly

  PRINCIPAL INVESTIGATOR

• Maria Karapetsa, MD

  University of Thessaly-University Hospital of Larissa,ICU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 12, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

GR (1)