Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01141556
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2010-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2010-06-08', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'length of ICU stay in hours', 'timeFrame': 'outcome at 28 days'}, {'measure': 'incidence of acute renal failure', 'timeFrame': '28 days'}, {'measure': 'total requirement of vasoconstrictors', 'timeFrame': '28 days'}, {'measure': 'total requirement of fluid replacement therapy', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['selenium', 'clinical outcome', 'heart surgery'], 'conditions': ['Heart; Surgery, Heart, Functional Disturbance as Result', 'Self Efficacy']}, 'referencesModule': {'references': [{'pmid': '28502744', 'type': 'DERIVED', 'citation': 'Schmidt T, Pargger H, Seeberger E, Eckhart F, von Felten S, Haberthur C. Effect of high-dose sodium selenite in cardiac surgery patients: A randomized controlled bi-center trial. Clin Nutr. 2018 Aug;37(4):1172-1180. doi: 10.1016/j.clnu.2017.04.019. Epub 2017 May 2.'}]}, 'descriptionModule': {'briefSummary': 'Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.', 'detailedDescription': 'Selenium is a essential micronutrient that is present in form of selenocysteine in many enzymes. Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality. Different studies showed that selenium supplementation had beneficial effects in critically ill patients with systemic inflammatory response syndrome (SIRS), reducing the rate of infectious complications and length of hospital stay.\n\nHeart surgery is associated with a complex systemic inflammatory response and the extent correlates with the development of postoperative complications. Former clinical trials used selenium supplementation with a loading dose of normally 1000 to 2000 μg, followed by a daily dosage of 1000 μg. With these dosage regimes pharmacological investigations demonstrated a delayed increase of the selenium concentration in plasma and whole blood. As a result a delayed increase of selenoenzymes can be assumed.\n\nAim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.\n\nPrimary endpoints are: Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score and the length of ICU stay in hours.\n\nSecondary endpoints are: incidence of acute renal failure, total requirement of vasoconstrictors and fluid replacement therapy\n\nInclusion criteria: written informed consent, males and females age ≥ 18 years, patients undergoing an elective heart surgery, normal renal function (serum creatinine ≤ 200 μmol/l)\n\nExclusion criteria: pregnancy, lack of written concent, emergency operation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* males and females age ≥ 18 years\n* patients undergoing an elective heart surgery\n* normal renal function (serum creatinine ≤ 200 μmol/l)\n\nExclusion Criteria:\n\n* pregnancy\n* lack of written concent\n* emergency operation'}, 'identificationModule': {'nctId': 'NCT01141556', 'briefTitle': 'Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction', 'orgStudyIdInfo': {'id': '236/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days)', 'interventionNames': ['Drug: Selenase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Selenase', 'description': 'Selenase Bolus 4000 microgram i.v. intraoperatively, followed by an daily bolus of Selenase 1000 microgram i.v. until discharge from ICU (no longer than 13 days)', 'interventionNames': ['Drug: Selenase']}], 'interventions': [{'name': 'Selenase', 'type': 'DRUG', 'otherNames': ['Selenase: Selenium'], 'description': 'After enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days).', 'armGroupLabels': ['Placebo', 'Selenase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6016', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Kantonsspital Luzern', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Departement of Anaesthesia and Intensive Care, University Hospital of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '6016', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Kantonsspital Luzern', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Christoph Haberthuer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anästhesie/chirurgische Intensivstation Luzerner Kantonsspital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}