NCT02026856

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Pavol Jozef Safarik University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Severe Sepsis

Interventions

Type	Name	Description
DRUG	sodium selenite pentahydrate
OTHER	placebo - continuous saline NaCl 50 ml

Timeline

• Start date: 2013-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-01-03
• Last updated: 2017-04-10

Locations

1 site across 1 country: Slovakia