Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04014218
Status:
UNKNOWN
Last Update Posted:
2019-07-10
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'opaque envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28 days after ICU admission', 'description': '28 days and in-hospital mortality'}, {'measure': 'ICU Length of stay (LOS)', 'timeFrame': '45 days after ICU admission', 'description': 'Length of stay in ICU'}, {'measure': 'Length of mechanical ventilation (LMV)', 'timeFrame': '45 days after ICU admission', 'description': 'Length of mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'P/F Ratio', 'timeFrame': '45 days after ICU admission', 'description': 'minimal pO2/FiO2'}, {'measure': 'Delirium', 'timeFrame': '5 days after ICU admission', 'description': 'onset and duration of delirium'}, {'measure': 'MACCE', 'timeFrame': '28 days after ICU admission', 'description': 'Major Adverse Cardiac and Cerebrovascular Event'}, {'measure': 'event of RRT', 'timeFrame': '28 days after ICU admission', 'description': 'event of Renal Replacement Therapy'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedation', 'ARDS', 'sepsis', 'outcome'], 'conditions': ['ARDS']}, 'descriptionModule': {'briefSummary': 'Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sepsis\n* ARDS\n* P/F Ratio 100-250\n* start of mechanical ventilation\n\nExclusion Criteria:\n\n* pregnancy\n* concomitant oncological disease\n* prior psychological impairment'}, 'identificationModule': {'nctId': 'NCT04014218', 'briefTitle': 'Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Moscow Regional Research and Clinical Institute (MONIKI)'}, 'officialTitle': 'Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.', 'orgStudyIdInfo': {'id': 'SS2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhalation sedation', 'interventionNames': ['Drug: Inhalation Sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'interventionNames': ['Drug: Intravenous Sedation']}], 'interventions': [{'name': 'Inhalation Sedation', 'type': 'DRUG', 'description': 'Inhalation Sedation by Administration of Sevoflurane', 'armGroupLabels': ['Inhalation sedation']}, {'name': 'Intravenous Sedation', 'type': 'DRUG', 'description': 'Intravenous Sedation by Administration of Propofol', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '129110', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Valery V Likhvantsev, Professor', 'role': 'CONTACT', 'email': 'lik0704@gmail.com', 'phone': '+7 (903) 623-59-82'}], 'facility': 'Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Valery V Likhvantsev,', 'role': 'CONTACT', 'email': 'lik0704@gmail.com', 'phone': '+7 (903) 623-59-82'}], 'overallOfficials': [{'name': 'Valery V Likhvantsev,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Regional Clinical and Research Institute, Department of Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Regional Research and Clinical Institute (MONIKI)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute', 'investigatorFullName': 'Valery V. Likhvantsev, Professor', 'investigatorAffiliation': 'Moscow Regional Research and Clinical Institute (MONIKI)'}}}}