Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06152458
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D013831', 'term': 'Thiamine'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-09-01', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ventilation', 'timeFrame': 'intensive care unit discharge (up to 90 days)', 'description': 'duration of mechanical ventilation (days)'}, {'measure': 'vasopressors', 'timeFrame': 'intensive care unit discharge (up to 90 days)', 'description': 'length of circulatory support (days)'}, {'measure': 'Length of stay', 'timeFrame': 'intensive care unit discharge (up to 90 days)', 'description': 'length of Intensive care unit staying (days)'}, {'measure': 'main mortality', 'timeFrame': 'intensive care unit discharge (up to 90 days)', 'description': 'all-cause mortality (dead/survived) in the intensive care unit'}], 'secondaryOutcomes': [{'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- se-carbamide (mg/dl)'}, {'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- se-creatinine (µmol/L)'}, {'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- plateletes (G/L),'}, {'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- procalcitonin (ng/ml),'}, {'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- white blood cells (G/L)'}, {'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- heat shock C-reactive protein (mg/L)'}, {'measure': 'secondary outcomes', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'development of inflammatory laboratory parameters:\n\n\\- se-lactate (mmol/L)'}, {'measure': 'antibiotics', 'timeFrame': 'intensive care unit discharge (up to 90 days)', 'description': 'the length of antibiotic treatment (days)'}, {'measure': 'PiCCO parameters', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'changes in invasive hemodynamic parameters-PiCCO ®:\n\n\\- cardiac index (l/min/m2)'}, {'measure': 'PiCCO parameters', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'changes in invasive hemodynamic parameters-PiCCO ®:\n\n\\- extravascular lung water (ml/kg)'}, {'measure': 'PiCCO parameters', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'changes in invasive hemodynamic parameters-PiCCO ®:\n\n\\- intrathoracic body water (ml/m2)'}, {'measure': 'PiCCO parameters', 'timeFrame': 'up to 5 days after admission to intensive care', 'description': 'changes in invasive hemodynamic parameters-PiCCO ®:\n\n\\- myocardial contractility (dP/dTmax- (mm hg/s)'}, {'measure': "other mortality's", 'timeFrame': 'up to 60 days after admission to intensive care', 'description': 'in-hospital, 30- and 60-day mortality (dead/survived)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'vitamin-c', 'thiamine', 'septic shock'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction.\n\nAim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients.\n\nMaterial and methods: In our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical analysis.\n\nEthical license: 7849-PTE 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* septic shock\n* intensive care unit administration\n\nExclusion Criteria:\n\n* under age 18\n* above age 80\n* moribund patients\n* pregnant patients\n* active kidney stone\n* inability to obtain consent\n* viral or mixed sepsis\n* missed dose of vitamin C/ thiamin or hydrocortisone\n* Physician refused\n* Vitamin C / Thiamine/ Hydrocortisone for other indications'}, 'identificationModule': {'nctId': 'NCT06152458', 'briefTitle': 'Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.', 'orgStudyIdInfo': {'id': '7849-PTE 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Patients in the intervention group (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.', 'interventionNames': ['Drug: Vitamin C']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'As a control group, we selected 20 age- and sex-matched patients with septic shock who did not receive vitamin treatment.They received the standard of care for septic shock.'}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['Thiamine'], 'description': 'Patients in the intervention group (G1) (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7624', 'city': 'Pécs', 'state': 'Baranya', 'country': 'Hungary', 'facility': 'Department of Anaesthesia and Intensive Therapy University of Pecs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}