Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 5:51 PM
Study NCT ID:
NCT04964492
Status:
UNKNOWN
Last Update Posted:
2023-02-10
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056987', 'term': 'Vasoplegia'}, {'id': 'D012769', 'term': 'Shock'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients responding to treatment with HCB', 'timeFrame': '1 hour', 'description': 'A patient will be defined as a responder to hydroxocobalamin infusion if there is an increase of more than 20% in average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.'}], 'secondaryOutcomes': [{'measure': 'The change in average blood pressure over time in responder patients', 'timeFrame': 'one hour', 'description': 'Blood pressure is measured in units of millimeters of mercury (mmHg).'}, {'measure': 'The change in average blood pressure over time in non-responder patients', 'timeFrame': 'one hour', 'description': 'Blood pressure is measured in units of millimeters of mercury (mmHg).'}, {'measure': 'The change in doses of NAd (mg/h) in responder patients', 'timeFrame': 'one hour'}, {'measure': 'The change in doses of NAd (mg/h) in non-responder patients', 'timeFrame': 'one hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vasoplegia', 'hydroxocobalamin', 'hemodynamics', 'intensive care unit', 'shock'], 'conditions': ['Vasoplegia', 'Hemodynamics', 'Intensive Care Unit', 'Shock']}, 'descriptionModule': {'briefSummary': 'Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).\n\nHCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.\n\nThe investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.', 'detailedDescription': 'Vasoplegic shock is defined by arterial hypotension, a high cardiac output with a normal or high cardiac index, collapsed systemic vascular resistance (SVR) and high dose of norepinephrine in the absence of hypovolaemia. The drop in secondary organ perfusion pressure ultimately leads to multiple organ failure and death.\n\nThrough clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).\n\nHCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.\n\nThe investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All SVR (systemic vascular resistance) patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included. Patients who received treatment for another indication were not included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All SVR patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included.\n\nExclusion Criteria:\n\n* Patients who received treatment for another indication were not included.'}, 'identificationModule': {'nctId': 'NCT04964492', 'acronym': 'VASOKIT', 'briefTitle': 'Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock', 'orgStudyIdInfo': {'id': 'PI2020_843_0124'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'responders to treatment', 'description': 'A patient will be defined as a responder to hydroxocobolamin infusion if there is an increase of more than 20% in Average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.'}, {'label': 'non-responders to treatment', 'description': 'A patient will be defined as a non-responder to hydroxocobolamin infusion if there is not an increase of more than 20% in Average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Huette, MD', 'role': 'CONTACT', 'email': 'huette.pierre@chu-amiens.fr', 'phone': '03 22 08 78 99'}], 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Pierre HUETTE, MD', 'role': 'CONTACT', 'email': 'huette.pierre@chu-amiens.fr', 'phone': '03 22 08 78 99'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}