Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT04958668
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2021-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Volatile Sedation After Heart Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to extubation', 'timeFrame': 'through study completion, an average of 2 days', 'description': 'Time from admission on ICU until awakening and Extubation.'}], 'secondaryOutcomes': [{'measure': 'Time to neurocognitive assessability', 'timeFrame': 'through study completion, an average of 2 days', 'description': 'Time from admission on ICU until awake and neurocognitive assessable.'}, {'measure': 'Required setup time of the intensive care workplace', 'timeFrame': 'through study completion, up to 24 hours', 'description': 'Required setup time of the intensive care workplace to provide volatile or intravenous sedation.'}, {'measure': 'Factor related to the course of intensive care: blood loss', 'timeFrame': 'through study completion, an average of 24 hours', 'description': 'Measured Postoperative Blood Loss'}, {'measure': 'Factor related to the course of intensive care: kidney injury', 'timeFrame': 'through study completion, an average of 24 hours', 'description': 'Measured increases in serum renal retention levels: creatinine and urea in terms of renal failure according to Kidney Disease - Improving Global Outcomes (KDIGO) criteria.'}, {'measure': 'Factor related to the course of intensive care: acid-base balance', 'timeFrame': 'through study completion, an average of 24 hours', 'description': 'Measured serum lactate levels and hypercapnia'}, {'measure': 'Factor related to the course of intensive care: lung function parameters', 'timeFrame': 'through study completion, an average of 24 hours', 'description': 'Required inspiratory oxygen fraction'}, {'measure': 'Factor related to the course of intensive care:cardiovascular medication', 'timeFrame': 'through study completion, an average of 24 hours', 'description': 'Required dosage of adrenaline, noradrenaline, vasopressin or milrinone'}, {'measure': 'Factors related to the course of operative procedure', 'timeFrame': 'through study completion, up to 24 hours', 'description': 'time of the intraoperative procedure including the heart-lung-machine'}, {'measure': 'Intra-hospital mortality', 'timeFrame': 'through study completion, an average of 7 days', 'description': 'Intra-hospital mortality - Safety outcome'}, {'measure': 'Liver failure', 'timeFrame': 'through study completion, an average of 7 days', 'description': 'Intra-hospital liver failure - Safety outcome'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': 'through study completion, up to 24 hours', 'description': 'Detection of postoperative nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valve Heart Disease', 'Awakening Early']}, 'referencesModule': {'references': [{'pmid': '38581030', 'type': 'DERIVED', 'citation': 'Flinspach AN, Raimann FJ, Kaiser P, Pfaff M, Zacharowski K, Neef V, Adam EH. Volatile versus propofol sedation after cardiac valve surgery: a single-center prospective randomized controlled trial. Crit Care. 2024 Apr 5;28(1):111. doi: 10.1186/s13054-024-04899-y.'}, {'pmid': '35197356', 'type': 'DERIVED', 'citation': 'Flinspach AN, Herrmann E, Raimann FJ, Zacharowski K, Adam EH. Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial. BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804.'}]}, 'descriptionModule': {'briefSummary': 'Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids.\n\nThe study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Valve reconstruction or valve replacement\n* Must be capable to giving written consent\n\nExclusion Criteria:\n\n* Intolerance to volatile anaesthetics (e.g. malignant hyperthermia)\n* Severe obstructive pulmonary disease\n* Extended aortic arch or ascending aorta surgery\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT04958668', 'briefTitle': 'Prospective Evaluation of Volatile Sedation After Heart Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Prospective Evaluation of Volatile Sedation With Regard to Awakening Behaviour and Extubation Capacity in Patients Undergoing Heart Valve Surgery', 'orgStudyIdInfo': {'id': '20-1050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Volatile procedere', 'description': 'Intensive care treatment with demand-adapted sedation with volatile anaesthetics', 'interventionNames': ['Other: Post-operative intensive care using volatile sedation']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional procedere', 'description': 'Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives'}], 'interventions': [{'name': 'Post-operative intensive care using volatile sedation', 'type': 'OTHER', 'description': 'Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management..', 'armGroupLabels': ['Volatile procedere']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Armin N Flinspach, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JWGoethe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Armin N. Flinspach', 'investigatorAffiliation': 'Goethe University'}}}}