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

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.

Study Overview

• Status: Completed
• Conditions: Severe Sepsis
• Intervention / Treatment: 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
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Slovakia
  • Košice, Slovakia, 041 90
    • 1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
antioxidant enzymes	2 years

Collaborators and Investigators

• Sponsor: Pavol Jozef Safarik University

Publications and helpful links

General Publications

• Kocan L, Vaskova J, Vasko L, Lakyova L, Kocanova H, Simonova J, Simon R, Firment J. [Acute multiple organ failure after endoscopic polypectomy]. Cas Lek Cesk. 2012;151(12):568-72. Slovak.
• Kocan L, Firment J, Simonova J, Vaskova J, Guzy J. [Selenium supplementation in patients with severe acute pancreatitis]. Rozhl Chir. 2010 Aug;89(8):518-21. Slovak.
• Kocan L, Vaskova J, Vasko L, Simonova J, Simon R, Firment J. Selenium adjuvant therapy in septic patients selected according to Carrico index. Clin Biochem. 2014 Oct;47(15):44-50. doi: 10.1016/j.clinbiochem.2014.07.004. Epub 2014 Jul 12.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (ESTIMATE): January 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: oxidative stress, sepsis, selenium
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Selenious Acid; Sodium Selenite
• Other Study ID Numbers: Se-AOX 109/2011