Clinical trial NCT02026856: Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
Official title: Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Keywords: oxidative stress, sepsis, selenium
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: mortality
timeFrame: 2 years
Secondary outcomes:
measure: The oxygenation index
timeFrame: 2 years
Other outcomes:
measure: antioxidant enzymes
timeFrame: 2 years
Locations:
city: Košice
country: Slovakia
facility: 1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.