Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: sodium selenite pentahydrate
* Other: placebo - continuous saline NaCl 50 ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Se-OI> 200<br>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<br> <br> |
| Se-OI <200<br>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<br> <br> |
| Placebo-OI> 200<br>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<br> <br> |
| Placebo-OI <200<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The oxygenation index | PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxidative stress, sepsis, selenium