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Trial record 24 of 1556 for:    Slovakia

Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis (Se-AOX)

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ClinicalTrials.gov Identifier: NCT02026856
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Kočan Ladislav, Pavol Jozef Safarik University

Brief Summary:
This study looked at parenteral administration of selenium to septic patients and subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the development of clinical status.

Condition or disease Intervention/treatment
Severe Sepsis Drug: sodium selenite pentahydrate Other: placebo - continuous saline NaCl 50 ml

Detailed Description:

Patients will be divided into two groups. Se-group who received selenium supplementation during hospitalization in the 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) (Selenase, Vivax; selenium hereinafter).

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.


Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
Study Start Date : December 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
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
Drug: 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
Drug: 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
Other: 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
Other: placebo - continuous saline NaCl 50 ml



Primary Outcome Measures :
  1. mortality [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The oxygenation index [ Time Frame: 2 years ]
    PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen)


Other Outcome Measures:
  1. antioxidant enzymes [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients with APACHE II score between 19 and 24 points after admission with sepsis, severe sepsis or septic shock during hospitalization as defined by the International Sepsis Definitions Conference
Criteria

Inclusion Criteria:

  • sepsis, severe sepsis or septic shock, APACHE II score between 19 and 24 points after admission

Exclusion Criteria:

  • mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026856


Locations
Slovakia
1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur
Košice, Slovakia, 041 90
Sponsors and Collaborators
Pavol Jozef Safarik University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kočan Ladislav, MD PhD, Pavol Jozef Safarik University
ClinicalTrials.gov Identifier: NCT02026856     History of Changes
Other Study ID Numbers: Se-AOX 109/2011
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: December 2013

Keywords provided by Kočan Ladislav, Pavol Jozef Safarik University:
oxidative stress, sepsis, selenium

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Selenium
Selenious Acid
Sodium Selenite
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances