Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
NCT ID: NCT02026856
Last Updated: 2017-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4 participants
OBSERVATIONAL
2013-12-31
2013-12-31
Brief Summary
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Detailed Description
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The placebo group will receive continuous saline NaCl 50 ml/day for 6 days as a continuous infusion (excluding additional infusion therapy). Patients will be further divided into subgroups according to OI on the day of admission to ICU. The oxygenation index (OI) PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) ratio in patients will be calculated daily.
The determination of biochemical and hematological parameters of blood samples will be as a part of the routine diagnostic methods. Data collection for the Se-AOX study will be performed at two-day intervals: T1 (1st-2nd day), T2 (3rd-4th day) and T3 (5th-6th day). Kinetic methods for estimating the activities of glutathione peroxidase (GPx, E.C. 1.11.1.9), glutathione reductase (GR, E.C.1.6.4.2) will be performed using a kit (Sigma-Aldrich, Germany) and that of superoxide dismutase (SOD, E.C. 1.15.1.1) by means of the SOD-Assay Kit-WST (Fluka, Japan) following the user manual provided.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Se-OI> 200
patients who received form of sodium selenite pentahydrate at 750 mg/day for 6 days immediately after admission to our department (1000 mg of sodium selenite pentahydrate = 333 micrograms of selenium) and oxygenation index (OI) by PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) was higher than 200
sodium selenite pentahydrate
Se-OI <200
patients who received form of sodium selenite pentahydrate at 750 mg/day for 6 days immediately after admission to our department (1000 mg of sodium selenite pentahydrate = 333 micrograms of selenium) and oxygenation index (OI) by PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) was lower than 200
sodium selenite pentahydrate
Placebo-OI> 200
patients who received continuous saline NaCl 50 ml/day for 6 days as a continuous infusion (excluding additional infusion therapy) and oxygenation index (OI) by PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) was higher than 200
placebo - continuous saline NaCl 50 ml
Placebo-OI <200
patients who who received continuous saline NaCl 50 ml/day for 6 days as a continuous infusion (excluding additional infusion therapy) and oxygenation index (OI) by PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) was lower than 200
placebo - continuous saline NaCl 50 ml
Interventions
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sodium selenite pentahydrate
placebo - continuous saline NaCl 50 ml
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Pavol Jozef Safarik University
OTHER
Responsible Party
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Kočan Ladislav
MD PhD
Locations
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1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur
Košice, , Slovakia
Countries
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References
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Kocan L, Vaskova J, Vasko L, Lakyova L, Kocanova H, Simonova J, Simon R, Firment J. [Acute multiple organ failure after endoscopic polypectomy]. Cas Lek Cesk. 2012;151(12):568-72. Slovak.
Kocan L, Firment J, Simonova J, Vaskova J, Guzy J. [Selenium supplementation in patients with severe acute pancreatitis]. Rozhl Chir. 2010 Aug;89(8):518-21. Slovak.
Kocan L, Firment J, Pirnikova I, Farkasova Iannaccone S, Rybar D, Gnorikova J, Korcek J, Kocanova H, Torok P, Rapcanova S, Vaskova J. Full recovery of lung tissue after severe viral pneumonia H1N1: A case report with 10 years follow-up. Medicine (Baltimore). 2023 Feb 22;102(8):e33052. doi: 10.1097/MD.0000000000033052.
Kocan L, Vaskova J, Vasko L, Simonova J, Simon R, Firment J. Selenium adjuvant therapy in septic patients selected according to Carrico index. Clin Biochem. 2014 Oct;47(15):44-50. doi: 10.1016/j.clinbiochem.2014.07.004. Epub 2014 Jul 12.
Other Identifiers
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Se-AOX 109/2011
Identifier Type: -
Identifier Source: org_study_id
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