Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-04 @ 4:43 AM
Study NCT ID:
NCT04747795
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2021-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-03', 'releaseDate': '2024-11-14'}], 'estimatedResultsFirstSubmitDate': '2024-11-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], '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': 'D000077330', 'term': 'Saline Solution'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-23', 'size': 416595, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-21T14:56', 'hasProtocol': False}]}}, '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': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sequential Organ Failure Assessment (SOFA) score', 'timeFrame': '5 days', 'description': 'Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)'}], 'secondaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days'}, {'measure': 'Maximum SOFA score', 'timeFrame': '5 days', 'description': 'Maximum SOFA score measured during 5 intervention period. SOFA score ranging from 0 to 24, with 24 begin the worst outcome (death)'}, {'measure': 'Length of hospital stay', 'timeFrame': '3 months', 'description': 'Total length of hospital stay of the patient (including beyond intervention period)'}, {'measure': 'Length of ICU stay', 'timeFrame': '3 months', 'description': 'Total length of ICU stay of the patient (including beyond intervention period)'}, {'measure': 'Duration Vasopressors', 'timeFrame': '5 days', 'description': 'Total duration where vasopression is required (hours)'}, {'measure': 'Dosage Vasopressors', 'timeFrame': '5 days', 'description': 'Total dosage of Vasopressors required (mcg/kg/min)'}, {'measure': 'need for Renal Replacement Therapy (RRT)', 'timeFrame': '5 days', 'description': 'was RRT needed'}, {'measure': 'duration of Renal Replacement Therapy (RRT)', 'timeFrame': '5 days', 'description': 'total duration of RRT (hours)'}, {'measure': 'Ventilator days', 'timeFrame': '3 months', 'description': 'Total number of days the patient requires ventilator support (including beyond intervention period)'}, {'measure': 'Steroids', 'timeFrame': '5 days', 'description': 'Total dose of steroids given'}, {'measure': 'Quality of life questionnaire (EQ-5D-5L)', 'timeFrame': '3 months', 'description': "The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.\n\nThe EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement."}, {'measure': 'Time to return to work', 'timeFrame': '3 months', 'description': 'Time to return to work of the patient after ED admission (in days)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin C', 'ascorbic acid', 'sepsis', 'septic shock', 'RCT'], 'conditions': ['Sepsis', 'Septic Shock', 'Sepsis, Severe']}, 'referencesModule': {'references': [{'pmid': '40269974', 'type': 'DERIVED', 'citation': 'Vandervelden S, Cortens B, Fieuws S, Eegdeman W, Malinverni S, Vanhove P, Monsieurs K, Breuls J, Hubloue I, Stifkens F, Creteur J, Wauters L, Desruelles D; C-EASIE investigators. Early administration of vitamin C in patients with sepsis or septic shock in emergency departments: a multicenter, double-blind, randomized controlled trial: the C-EASIE trial. Crit Care. 2025 Apr 23;29(1):160. doi: 10.1186/s13054-025-05383-x.'}, {'pmid': '34739527', 'type': 'DERIVED', 'citation': 'Vandervelden S, Wauters L, Breuls J, Fieuws S, Vanhove P, Hubloue I, Bartiaux M, Creteur J, Stifkens F, Monsieurs K, Desruelles D. Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol. PLoS One. 2021 Nov 5;16(11):e0259699. doi: 10.1371/journal.pone.0259699. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'In this clinical trial the effect of early administration of Vitamin C is investigated in patients admitted at the emergency department with sepsis or septic shock.\n\nWhen a patient has sepsis, his/her body is causing damage to its own tissues and organs as result of an infection. This can lead to septic shock. The patient has a low blood pressure, his/her organs stop working and the patient may even die.\n\nThe aim of this trial is to investigate the efficiency of Vitamin C in sepsis and septic shock. Vitamin C is a vitamin present in various foods and has been approved as dietary supplement by the Belgian authorities. Over the years it has been proven that Vitamin C is very safe. In addition, several studies have shown that Vitamin C can also have a protective effect. It can reduce organ damage and increase survival rates. Although several studies suggest that Vitamin C can help fight sepsis, it is not yet used in practice. This Belgian trial, in which several hospitals participate, hopes to provide a clear answer to the question: "Should Vitamin C be administered to patients admitted in an emergency department with sepsis or septic shock?"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has a 'suspected infection': this requires the combination of antibiotic administration and body fluid cultures within the first 6 hours after Emergency Department presentation.\n* Patient has a NEWS score ≥ 5.\n\nExclusion Criteria:\n\n* Patient (≥18 years old) or legally authorized representative didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available.\n* antibiotic administration as a single dose or as a prophylactic treatment.\n* antibiotics administered without an accompanying body fluid culture according to the timeframe (within 6 hours after emergency department presentation).\n* 'Do no intubate' or 'comfort measures only' status.\n* Failure to randomize within 6 hours after Emergency Department presentation.\n* Weight \\< 45 kg.\n* Pregnant or breastfeeding.\n* Known allergy for Vitamin C.\n* Known history of oxalate nephropathy or hyperoxaluria.\n* Known history of glucose-6-phosphate dehydrogenase deficiency.\n* Known history of chronic iron overload due to iron storage and other diseases.\n* The patient is already on IV steroids for a reason other than septic shock.\n* Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID-19 within 14 days prior to or at ED presentation).\n* Participation in an interventional trial with an investigational medicinal product (IMP) or device"}, 'identificationModule': {'nctId': 'NCT04747795', 'acronym': 'c-easie', 'briefTitle': 'Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments: a Multicentre, Double Blinded, Randomized Controlled Trial: the C-EASIE Trial', 'orgStudyIdInfo': {'id': 'S63213'}, 'secondaryIdInfos': [{'id': '2020-001862-12', 'type': 'EUDRACT_NUMBER'}, {'id': 'KCE 19-1237', 'type': 'OTHER_GRANT', 'domain': 'Federaal kenniscentrum voor de gezondheidszorg (KCE)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'standard care + placebo', 'description': "The 'standard care' group will receive intermittent infusion of normal saline (3 ampoules of 5 ml 9mg/ml normal saline diluted in 50 ml of normal saline, every 6 hours) during 4 days or until hospital discharge and is started within 6 hours after presentation (time of triage) in the ED.", 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard care + Vitamin C', 'description': "The 'standard care + Vitamin C' group will receive intermittent infusion of Vitamin C (3 ampoules of 500 mg/5ml Vitamin C diluted in 50 ml of normal saline, every 6 hours) during 4 days or until hospital discharge and is started within 6 hours after presentation (time of triage) in the ED.", 'interventionNames': ['Drug: Vitamin C']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['Ascorbic Acid'], 'description': 'IV', 'armGroupLabels': ['standard care + Vitamin C']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['physiological serum', 'placebo'], 'description': 'IV', 'armGroupLabels': ['standard care + placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GasthuisZusters Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Saint-Pierre Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Université Libre de Bruxelles Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Turnhout', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}], 'overallOfficials': [{'name': 'Didier Desruelles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federaal Kenniscentrum voor Gezondheidszorg, Belgium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-14', 'type': 'RELEASE'}, {'date': '2025-01-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Universitaire Ziekenhuizen KU Leuven'}}}}