Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-03 @ 9:10 AM
Study NCT ID:
NCT02978066
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postspinal Hypotension and Cardiac Performance in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke volume in ml', 'timeFrame': '0-45 minutes after spinal anaesthesia', 'description': 'the blood volume pumped by the heart at each stroke'}], 'secondaryOutcomes': [{'measure': 'Arterial blood pressure mmHg and change from baseline', 'timeFrame': '0-45 minutes after spinal anaesthesia', 'description': 'mmHg measured by arterial catheter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ARTHROPLASTY, REPLACEMENT; ANESTHESIA']}, 'descriptionModule': {'briefSummary': 'Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 years or older scheduled for hip or knee arthroplasty in spinal anaesthesia. Exclusion criteria were: (i) weight \\<40kg; (ii) concomitant lithium medication; (iv) informed consent not obtained; (v) research team unavailable', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hip or knee arthroplasty\n* spinal anaesthesia\n* age 65 years or more\n\nExclusion Criteria:\n\n* weight \\<40kg\n* concomitant lithium medication\n* written informed consent not obtained\n* research team unavailable'}, 'identificationModule': {'nctId': 'NCT02978066', 'briefTitle': 'Postspinal Hypotension and Cardiac Performance in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study', 'orgStudyIdInfo': {'id': '2010-2042-31/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spinal anaesthesia', 'type': 'OTHER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Professor', 'investigatorFullName': 'Sigridur Kalman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}