Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT02026856
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2013-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018038', 'term': 'Sodium Selenite'}], 'ancestors': [{'id': 'D020887', 'term': 'Selenious Acid'}, {'id': 'D018036', 'term': 'Selenium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2013-12-31', 'studyFirstSubmitQcDate': '2013-12-31', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'antioxidant enzymes', 'timeFrame': '2 years'}], 'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'The oxygenation index', 'timeFrame': '2 years', 'description': 'PaO2/FiO2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oxidative stress, sepsis, selenium'], 'conditions': ['Severe Sepsis']}, 'referencesModule': {'references': [{'pmid': '23387814', 'type': 'BACKGROUND', '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.'}, {'pmid': '21121149', 'type': 'RESULT', '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.'}, {'pmid': '36827018', 'type': 'DERIVED', 'citation': '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': '25020262', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sepsis, severe sepsis or septic shock, APACHE II score between 19 and 24 points after admission\n\nExclusion Criteria:\n\n* mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria'}, 'identificationModule': {'nctId': 'NCT02026856', 'acronym': 'Se-AOX', 'briefTitle': 'Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Pavol Jozef Safarik University'}, 'officialTitle': 'Therapeutic Effect of Sodium Selenite on Oxidative Stress in Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': 'Se-AOX 109/2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Se-OI> 200', 'description': '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', 'interventionNames': ['Drug: sodium selenite pentahydrate']}, {'label': 'Se-OI <200', 'description': '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', 'interventionNames': ['Drug: sodium selenite pentahydrate']}, {'label': 'Placebo-OI> 200', 'description': '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', 'interventionNames': ['Other: placebo - continuous saline NaCl 50 ml']}, {'label': 'Placebo-OI <200', 'description': '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', 'interventionNames': ['Other: placebo - continuous saline NaCl 50 ml']}], 'interventions': [{'name': 'sodium selenite pentahydrate', 'type': 'DRUG', 'armGroupLabels': ['Se-OI <200', 'Se-OI> 200']}, {'name': 'placebo - continuous saline NaCl 50 ml', 'type': 'OTHER', 'armGroupLabels': ['Placebo-OI <200', 'Placebo-OI> 200']}]}, 'contactsLocationsModule': {'locations': [{'zip': '041 90', 'city': 'Košice', 'country': 'Slovakia', 'facility': '1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pavol Jozef Safarik University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Kočan Ladislav', 'investigatorAffiliation': 'Pavol Jozef Safarik University'}}}}