Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT02915627
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of blood pressure changes with and without garment application', 'timeFrame': 'Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'description': 'a measurement of blood pressure upon application of the non-pneumatic anti-shock garments'}], 'secondaryOutcomes': [{'measure': 'Assessment of changes in Baroreflex Sensitivity with and without garment application.', 'timeFrame': 'Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'description': 'baroreflex sensitivity; upon application of the anti-shock garments;'}, {'measure': 'Assessment of changes in trends in beat to beat blood pressure with and without garment application.', 'timeFrame': 'Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'description': 'trends in beat-to-beat blood pressure upon application of the anti-shock garments'}, {'measure': 'Assessment of participant tolerability with garment application.', 'timeFrame': 'Participants will be examined for a 15 minute interval with the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'description': 'Participant tolerability of the anti-shock garments'}, {'measure': 'Assessment of changes in ejection fraction with and without garment application.', 'timeFrame': 'Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'description': 'changes in ejection fraction upon application of anti-shock garment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antishock Garment'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '31937266', 'type': 'DERIVED', 'citation': 'Marinovich R, Li Z, Tamasi T, Quinn K, Wong S, McIntyre CW. Hemodynamic response to non-pneumatic anti-shock compression garments in patients with renal dysfunction. BMC Nephrol. 2020 Jan 14;21(1):15. doi: 10.1186/s12882-019-1680-8.'}]}, 'descriptionModule': {'briefSummary': 'Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). Each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.', 'detailedDescription': 'Primary Aim: To determine how blood flow restriction to the lower extremities using non-pneumatic anti-shock garments affects hemodynamic and cardiovascular parameters such as blood pressure in Hemodialysis (HD) patients while they are not on dialysis.\n\nInvestigators propose a pilot study to assess the effects of blood flow restriction using non-pneumatic anti-shock garments in HD patients while they are not on dialysis.\n\nOutcomes: The primary objective will be a measurement of blood pressure upon application of the non-pneumatic anti-shock garments.\n\nSecondary outcomes will include the following: baroreflex sensitivity; trends in beat-to-beat blood pressure upon application of the anti-shock garments; patient tolerability of the non-pneumatic anti-shock garments, ejection fraction via echocardiogram analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy participants\n\n1. Male and female, age≥18 years old\n2. No clinical diagnosis of CKD\n\nCKD patients not on dialysis\n\n1. Male and female, age≥18 years old\n2. Stage 4 or Stage 5 CKD patients\n\nCKD patients on dialysis\n\n1. Male and female, age≥18 years old\n2. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility\n\nExclusion Criteria:\n\n1. Not meeting inclusion criteria\n2. Severe heart failure (New York Heart Association grade IV)\n3. Pulmonary hypertension\n4. Mitral stenosis\n5. Cardiac transplant recipients\n6. Mental incapacity to consent\n7. Declined to participate\n8. Absence of lower limbs or lower limb injury\n9. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02915627', 'briefTitle': 'Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments', 'orgStudyIdInfo': {'id': '108183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy participants', 'description': 'Non chronic kidney disease (CKD) participants. Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'interventionNames': ['Device: Application of Antishock garment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CKD patients not on dialysis', 'description': 'CKD 4/5 patients not on Dialysis- Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'interventionNames': ['Device: Application of Antishock garment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CKD patients on Dialysis', 'description': 'Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility-Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'interventionNames': ['Device: Application of Antishock garment']}], 'interventions': [{'name': 'Application of Antishock garment', 'type': 'DEVICE', 'description': 'anti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.', 'armGroupLabels': ['CKD patients not on dialysis', 'CKD patients on Dialysis', 'Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, UWO', 'investigatorFullName': 'Chris McIntyre', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}