Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT02201134
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2014-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2014-07-16', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients', 'timeFrame': 'at day 1', 'description': 'The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.'}], 'secondaryOutcomes': [{'measure': 'Determination of neurological prognostic of patients at ICU and hospital discharge', 'timeFrame': 'at day 1'}, {'measure': 'Determination of systemic complications and organ failures during hospitalisation', 'timeFrame': 'at day 1'}, {'measure': 'Evaluation of systemic inflammation and evolution with cytokines', 'timeFrame': 'at day 1'}, {'measure': 'Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)', 'timeFrame': 'at day 1', 'description': 'at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.'}]}, 'conditionsModule': {'keywords': ['Cardiac arrest', 'Therapeutic hypothermia', 'Sevoflurane', 'Sedation', 'Patient resuscitated from cardiac arrest', 'Requiring sedation', 'Adult patients', 'Patient covered by french health care system'], 'conditions': ['Cardiac Arrest', 'Therapeutic Hypothermia']}, 'descriptionModule': {'briefSummary': 'Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.', 'detailedDescription': 'Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients resuscitated from cardiac arrest and treated with therapeutic hypothermia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Adult patients ventilated requiring therapeutic hypothermia in ICU\n* Stable respiratory and hemodynamic conditions\n* Epinephrine and norepinephrine infusion rate \\< 1,5 g/kg/min\n* Consent of patients or family\n* Arterial line\n* Patients resuscitated after cardiac arrest\n* No Flow \\< 10 min\n* Low Flow \\< 20 min\n* Neutropenia \\< 1 G/L\n* Post traumatic cardiac arrest\n* Contraindication of halogenated anesthesics\n* Extra corporeal life support or intra aortic balloon pump\n\nExclusion Criteria:\n\n* -Pregnant woman\n* Hemodynamic instability\n* Brain death defined by the disappearance of brain stem reflexes'}, 'identificationModule': {'nctId': 'NCT02201134', 'acronym': 'SEVOCAR', 'briefTitle': 'SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia', 'orgStudyIdInfo': {'id': 'CHU-0199'}, 'secondaryIdInfos': [{'id': '2014-001196-31'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'sevoflurane', 'interventionNames': ['Drug: sevoflurane']}], 'interventions': [{'name': 'sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Sébastien PERBET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Estaing', 'class': 'OTHER'}, {'name': 'Hopital Gabriel Montpied', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}