Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 6:28 PM
Study NCT ID:
NCT02545920
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2015-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess Ear Blood Flow During Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-09-07', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in ear blood flow', 'timeFrame': 'day 1 dialysis session', 'description': 'percentage change in ear blood flow compared to initial ear blood flow'}], 'secondaryOutcomes': [{'measure': 'change in blood pressure', 'timeFrame': 'day 1 dialysis session', 'description': 'change in blood pressure in mmHg compared to starting blood pressure'}, {'measure': 'change in haematocrit volume status', 'timeFrame': 'day 1 dialysis session', 'description': 'percentage change in haematocrit'}, {'measure': 'record of hypotensive episodes during dialysis', 'timeFrame': 'day 1 dialysis session', 'description': 'record of nursing interventions including reduction in ultrafiltration volume, administration of intravenous fluids. Use of distress thermometer visual analogue scale to record patient symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['haemodialysis', 'hypotension'], 'conditions': ['Kidney Failure']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.', 'detailedDescription': '10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal.\n\nPatients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chronic kidney failure attending for regular dialysis treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18 years and older up to 80 years\n* Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.\n* Able to provide written informed consent obtained\n\nExclusion Criteria:\n\n* Patients unable to provide written informed consent\n* Patients using hearing aids\n* Patients who have had previous middle ear surgery\n* Patients not fulfilling inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02545920', 'briefTitle': 'To Assess Ear Blood Flow During Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear', 'orgStudyIdInfo': {'id': '15/0310'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW32QG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'winnie Han', 'role': 'CONTACT', 'email': 'w.han@ucl.ac.uk', 'phone': '442077940500'}], 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'vashist deelchand', 'role': 'CONTACT', 'email': 'vashist.deelchand@nhs.net', 'phone': '02077940500'}], 'overallOfficials': [{'name': 'andrew davenport', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL Centre for Nephrology, Royal Free Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}