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

Severe Sepsis Clinical Trial

— Se-AOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026856
• Other study ID #: Se-AOX 109/2011
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: April 7, 2017
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Pavol Jozef Safarik University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

Drug:
• sodium selenite pentahydrate

Other:
• placebo - continuous saline NaCl 50 ml

Locations

Country	Name	City	State
Slovakia	1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur	Košice

Sponsors (1)

Lead Sponsor	Collaborator
Pavol Jozef Safarik University

Country where clinical trial is conducted

Slovakia, 

References & Publications (2)

Kocan L, Firment J, Simonová J, Vasková J, Guzy J. [Selenium supplementation in patients with severe acute pancreatitis]. Rozhl Chir. 2010 Aug;89(8):518-21. Slovak. — View Citation

Kocan L, Vašková J, Vaško L, Lakyová L, Kocanová H, Simonová J, Simon R, Firment J. [Acute multiple organ failure after endoscopic polypectomy]. Cas Lek Cesk. 2012;151(12):568-72. Slovak. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	antioxidant enzymes		2 years
Primary	mortality		2 years
Secondary	The oxygenation index	PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen)	2 years