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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02026856
Acronym
Se-AOX
Enrollment
4
Registered
2014-01-03
Start date
2013-12-31
Completion date
2013-12-31
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis

Keywords

oxidative stress, sepsis, selenium

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.

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.

Interventions

OTHERplacebo - continuous saline NaCl 50 ml

Sponsors

Pavol Jozef Safarik University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mortality2 years

Secondary

MeasureTime frameDescription
The oxygenation index2 yearsPaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen)

Other

MeasureTime frame
antioxidant enzymes2 years

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026