Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05155202
Status:
UNKNOWN
Last Update Posted:
2024-02-13
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000096003', 'term': 'Hypertensive Crisis'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000959', 'term': 'Antihypertensive Agents'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': 'During the twelve hours following start of drug infusion', 'description': 'Occurrence of worsening of hypoxemia'}], 'secondaryOutcomes': [{'measure': 'Efficacy of antihypertensive action', 'timeFrame': 'During the twelve hours following start of drug infusion', 'description': 'Time before the drop of arterial systolic blood pressure below 140mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemic Respiratory Failure', 'Side Effect', 'Hypertensive Emergency']}, 'descriptionModule': {'briefSummary': 'In the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among those drugs, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance.\n\nThe aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.', 'detailedDescription': 'Prospective observational study in 4 intensive care units in one general hospital and one university hospital.\n\nOnce Nicardipine or Urapidil infusion is started, data collection of respiratory related information such as type of ventilation, arterial partial pressure of oxygen, blood pressure, cardiac frequency.\n\nStatistical analysis for two qualitative variables: Group (Nicardipine or Urapidil) and occurrence or worsening of hypoxemia. Secondary outcoumes analysed such as maximal drop of blood pressure, evolution of the PaO2/FiO2 ratio, length of hospital stay, duration of mechanical ventilation in the ventilated patients.\n\nAnalysis for different subgroups : Patients with known atelectasis, postoperative of cardiac surgery, neuro-intensive care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All hypertensive patients in the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* With acute arterial systolic hypertension over 140mmHg\n* Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine\n\nExclusion Criteria:\n\n* Patient ventilated Under Nitrogen Monoxyde\n* Contraindication to Nicardipine or Urapidil\n* Refusal of the patient or his relatives\n* Patient treated for pulmonary hypertension'}, 'identificationModule': {'nctId': 'NCT05155202', 'acronym': 'ECRHIN-ICU', 'briefTitle': 'Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit. A Multicenter Prospective Observational Study Comparing Nicardipine and Urapidil', 'orgStudyIdInfo': {'id': 'ID2885'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nicardipine', 'description': 'Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine.', 'interventionNames': ['Drug: Antihypertensive Agents']}, {'label': 'Urapidil', 'description': 'Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil.', 'interventionNames': ['Drug: Antihypertensive Agents']}], 'interventions': [{'name': 'Antihypertensive Agents', 'type': 'DRUG', 'description': 'Administration of intravenous Nicardipine or Urapidil', 'armGroupLabels': ['Nicardipine', 'Urapidil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}