Severe SepsisSe-AOXNCT02026856
Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
An observational study of Severe Sepsis, run by Pavol Jozef Safarik University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- sodium selenite pentahydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteSlovakia
- Study dates
- Dec 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- sepsis, severe sepsis or septic shock, APACHE II score between 19 and 24 points after admission
Who cannot join
- mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur
Košice, 041 90
About this study
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.
Read the 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.
- Conditions
- Severe Sepsis
- Being tested
- sodium selenite pentahydrate, placebo - continuous saline NaCl 50 ml
- Keywords
- oxidative stress, sepsis, selenium
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium selenite pentahydrateDrug
placebo - continuous saline NaCl 50 mlOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: placebo - continuous saline NaCl 50 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 2 years
Secondary outcomes (1)
The oxygenation index
PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kočan Ladislav, Pavol Jozef Safarik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026856
- Sponsor's protocol ID
- Se-AOX 109/2011
- Acronym
- Se-AOX
- Status last verified
- Dec 2013
- First submitted
- 31 Dec 2013
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23387814Kocan 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.
PubMed 21121149Kocan 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.
PubMed 36827018Kocan 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.
PubMed 25020262
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT02026856
- Acronym / sponsor ID
- Se-AOX / Se-AOX 109/2011
- Conditions
- Severe Sepsis
- Keywords
- oxidative stress, sepsis, selenium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Se-OI> 200 | – | Drug: sodium selenite pentahydratepatients 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 |
| Se-OI <200 | – | Drug: sodium selenite pentahydratepatients 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 |
| Placebo-OI> 200 | – | Other: placebo - continuous saline NaCl 50 mlpatients 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 |
| Placebo-OI <200 | – | Other: placebo - continuous saline NaCl 50 mlpatients 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- sepsis, severe sepsis or septic shock, APACHE II score between 19 and 24 points after admission
Key exclusion criteria (1 listed)
- mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium selenite pentahydrate | Drug | Se-OI <200, Se-OI> 200 |
| placebo - continuous saline NaCl 50 ml | Other | Placebo-OI <200, Placebo-OI> 200 |
Primary outcome
mortality
Time frame: 2 years
1 secondary outcome
The oxygenation index
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 23387814Kocan 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.
- Results publication: PubMed 21121149Kocan 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.
- Derived from this study: PubMed 36827018Kocan 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.
- Derived from this study: PubMed 25020262Kocan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis, run by Pavol Jozef Safarik University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026856, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.