NCT02026856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
Last Updated

April 10, 2017

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

December 31, 2013

Last Update Submit

April 7, 2017

Conditions

Severe Sepsis

Keywords

oxidative stress, sepsis, selenium

Outcome Measures

Primary Outcomes (1)

  • mortality

    2 years

Secondary Outcomes (1)

  • The oxygenation index

    2 years

Other Outcomes (1)

  • antioxidant enzymes

    2 years

Study Arms (4)

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

Interventions

sodium selenite pentahydrateDRUG
Se-OI <200Se-OI> 200
placebo - continuous saline NaCl 50 mlOTHER
Placebo-OI <200Placebo-OI> 200

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • sepsis, severe sepsis or septic shock, APACHE II score between 19 and 24 points after admission

You may not qualify if:

  • mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Košice, 041 90, Slovakia

Location

Related Publications (4)

  • 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.

    PMID: 23387814BACKGROUND

  • 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.

    PMID: 21121149RESULT

  • Kocan L, Firment J, Pirnikova I, Farkasova Iannaccone S, Rybar D, Gnorikova J, Korcek J, Kocanova H, Torok P, Rapcanova S, Vaskova J. Full recovery of lung tissue after severe viral pneumonia H1N1: A case report with 10 years follow-up. Medicine (Baltimore). 2023 Feb 22;102(8):e33052. doi: 10.1097/MD.0000000000033052.

    PMID: 36827018DERIVED

  • 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.

    PMID: 25020262DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Sodium Selenite

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Selenious AcidSelenium CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 3, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 10, 2017

Record last verified: 2013-12

Locations

SL(1)