Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02042612
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007362', 'term': 'Intensive Care Units'}], 'ancestors': [{'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of plasmatic concentrations of sevoflurane before using AnaConda® system', 'timeFrame': 'at 5min, 60 min, 24 hrs and just before the end of sedation.'}], 'secondaryOutcomes': [{'measure': 'Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system', 'timeFrame': 'at 5min, 60 min, 24 hrs and just before the end of sedation.'}]}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Sevoflurane', 'Obesity', 'Sedation', 'ICU patients'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients', 'detailedDescription': 'Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI \\>30\n\nExclusion Criteria:\n\n* Acute kidney injury BMI \\<30 Sevoflurane anaphylaxia'}, 'identificationModule': {'nctId': 'NCT02042612', 'acronym': 'CISEVOB', 'briefTitle': 'Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients', 'orgStudyIdInfo': {'id': 'CHU-0176'}, 'secondaryIdInfos': [{'id': '2010-020044-35'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sevoflurane', 'description': 'Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients', 'interventionNames': ['Drug: Sedation with sevoflurane during 48-hr in ICU']}], 'interventions': [{'name': 'Sedation with sevoflurane during 48-hr in ICU', 'type': 'DRUG', 'otherNames': ['Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients'], 'armGroupLabels': ['sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU 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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}