Skip to main content
OpenTrials
Completed

NCT Number: NCT02026856

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur

Košice, 041 90, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium selenite pentahydrate

Drug

placebo - continuous saline NaCl 50 ml

Other

Primary outcomes

  1. mortality

    Time frame: 2 years

Secondary outcomes

  1. The oxygenation index

    Time frame: 2 years

    PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen)

Other outcomes

  1. antioxidant enzymes

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Pavol Jozef Safarik University

Other

Registry information

Acronym: Se-AOX

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 3, 2014
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.