Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT03744702
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2018-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056987', 'term': 'Vasoplegia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vasopressor duration in hours', 'timeFrame': 'Up to 10 days following surgery', 'description': 'Total duration of vasopressor therapy'}, {'measure': 'Vasopressor dose', 'timeFrame': 'Up to 10 days following surgery', 'description': 'Total dose of vasopressor in norepinephrine equivalents (mcg)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vasoplegia', 'cardiac surgery', 'ascorbic acid'], 'conditions': ['Vasoplegia']}, 'referencesModule': {'references': [{'pmid': '40400032', 'type': 'DERIVED', 'citation': 'Wieruszewski PM, Radosevich MA, Nei SD, Kashani KB, Normand SE, Schaff HV, Wittwer ED. Ascorbic acid and microcirculation in cardiothoracic surgery: a pilot feasibility trial and matched cohort study. J Cardiothorac Surg. 2025 May 22;20(1):234. doi: 10.1186/s13019-025-03486-8.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Ascorbic acid (Vitamin C) is an essential cofactor in the biosynthesis of catecholamines, and critically ill patients are known to be ascorbate-deficient. In addition, cardiopulmonary bypass (CPB) decreases ascorbic acid concentrations. Cardiac vasoplegia is the loss of vascular tone despite adequate volume status and cardiac output, occurring commonly in patients after CPB. This necessitates the administration of vasopressors and alternative agents which can have deleterious effects. The administration of ascorbic acid to cardiac surgical patients may improve microcirculatory function, enhance endogenous catecholamine levels and decrease the need for exogenous vasopressor support.', 'detailedDescription': '1\\. Specific Aims\n\nThe investigators aim to determine the feasibility of performing a study that can assess the impact of ascorbic acid administration on the development and severity of cardiac vasoplegia in cardiac surgical patients undergoing procedures at high risk for vasoplegia.\n\nSpecific Aim 1: Determine the feasibility of administration of high dose intravenous ascorbic acid in the operative and post-operative environments as well as sample size for a prospective, randomized, placebo controlled study.\n\nSpecific Aim 2: Determine baseline ascorbic acid plasma levels in a small cohort of cardiac surgical patients.\n\nSpecific Aim 3: Determine the impact of ascorbic acid administration on microvasculature as measured by dark field microscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 18 years of age or older\n* Undergoing cardiac surgery with the use of cardiopulmonary bypass\n* Undergoing myectomy or valve replacement/repair\n\nExclusion criteria:\n\n* Coronary artery bypass grafting (CABG)\n* Circulatory arrest\n* Active infection or sepsis\n* Severe hepatic disease or ascites\n* Pre-operative renal dysfunction requiring dialysis\n* Pre-operative midodrine\n* Pre-operative oral or intravenous steroid use'}, 'identificationModule': {'nctId': 'NCT03744702', 'briefTitle': 'Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery', 'orgStudyIdInfo': {'id': '18-003358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'All patients will receive ascorbic acid as this is a pilot study.', 'interventionNames': ['Drug: Ascorbic Acid']}], 'interventions': [{'name': 'Ascorbic Acid', 'type': 'DRUG', 'otherNames': ['Ascor'], 'description': 'Patients will receive IV ascorbic acid.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Erica D Wittwer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erica D. Wittwer, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}