Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT01342900
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Optimisation of Tissue Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of perioperative complications', 'timeFrame': 'during operation', 'description': 'organ dysfunction, SOFA score, troponin T, creatinin, CRP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tissue oxygenation', 'higk risk surgery', 'high risk patient', 'postoperative complications'], 'conditions': ['Higk Risk Surgery']}, 'referencesModule': {'references': [{'pmid': '25580087', 'type': 'DERIVED', 'citation': 'van Beest PA, Vos JJ, Poterman M, Kalmar AF, Scheeren TW. Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study. BMC Anesthesiol. 2014 Dec 16;14:122. doi: 10.1186/1471-2253-14-122. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications.\n\nTissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n. Major elective surgery\n\n* Aged over 65 years with moderate functional limitation of one or more organ systems\n* ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation\n* Routine use of arterial and central venous lines\n* Planned postoperative stay on ICU or PACU\n\nExclusion Criteria:\n\n* Refusal of consent\n* acute myocardial ischemia prior to enrolment\n* patients receiving palliative treatment only\n* disseminated malignancy\n* patients unlikely to survive more than 6 hours\n* emergency surgery\n* transplantations\n* neurosurgical patients\n* patients undergoing extensive liver surgery requiring low CVP management'}, 'identificationModule': {'nctId': 'NCT01342900', 'briefTitle': 'Intraoperative Optimisation of Tissue Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Intraoperative Monitoring and Optimisation of Tissue Oxygenation In High-Risk Surgical Patients for Reduction of Postoperative Complications: a Pilot Study', 'orgStudyIdInfo': {'id': 'IOTO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'The data from the InSPectra Monitor in the Control group will be inaccessible for the Investigator since this is not a part of their daily medical practice'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group,', 'description': 'The data given by the monitor will be available for the Investigator and used to apply the optimization protocol', 'interventionNames': ['Device: connected to the InSpectra Monitor']}], 'interventions': [{'name': 'connected to the InSpectra Monitor', 'type': 'DEVICE', 'armGroupLabels': ['Treatment group,']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Thomas W.L. Scheeren, Prof.dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.dr.', 'investigatorFullName': 'Prof.dr.T.W.L.Scheeren', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}