Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT03870594
Status:
UNKNOWN
Last Update Posted:
2019-03-12
First Post:
2019-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IDH in Diabetic Haemodialysis Patients and Association With Dialytic Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the correlation between diabetes and intradialytic hypotension', 'timeFrame': '4 weeks', 'description': 'Blood samples will be obtained for glycated hemoglobin, fasting blood glucose.Then patients will be divided into two groups DM, non DM.\n\nBlood pressure will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms'}, {'measure': 'the correlation between dialytic age and intradialytic hypotension', 'timeFrame': '4 weeks', 'description': 'Prior to the dialysis session,full history taking including age,duration of haemodialysis Blood pressure (BP) will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.\n\nIntradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intra-dialytic Hypotension']}, 'descriptionModule': {'briefSummary': 'Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension', 'detailedDescription': 'Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.Intradialytic hypotension is a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to The National Kidney Foundation.Intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. It is associated with poor long-term outcomes. Patients with Intradialytic hypotension show increased morbidity and mortality.The etiology of Intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. The main causes Intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,Impaired vasoconstriction induced by dysregulation of autonomic nervous system.\n\nDiabetes mellitus is the most common cause of chronic renal failure .Diabetic patients are more prone to cardiovascular diseases than non-diabetics .Although diabetes is in relation with hypertension ,It is associated with autonomic neuropathy which contribute to intradialytic hypotension . Recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital\n\nExclusion Criteria:\n\n* 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders'}, 'identificationModule': {'nctId': 'NCT03870594', 'briefTitle': 'IDH in Diabetic Haemodialysis Patients and Association With Dialytic Age', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intradialytic Hypotension in Diabetic Haemodialysis Patients and Its Association With Dialytic Age', 'orgStudyIdInfo': {'id': 'IDH in diabetic patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic', 'description': 'patients suffer from diabetes mellitus', 'interventionNames': ['Diagnostic Test: glycated hemoglobin']}, {'label': 'non diabetic', 'description': 'patients free from diabetes with normal blood glucose level', 'interventionNames': ['Diagnostic Test: glycated hemoglobin']}], 'interventions': [{'name': 'glycated hemoglobin', 'type': 'DIAGNOSTIC_TEST', 'description': 'hemoglobin A1c level in blood', 'armGroupLabels': ['diabetic', 'non diabetic']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud fawzy', 'role': 'CONTACT', 'email': 'mahmoudfawzy2490@yahoo.com', 'phone': '201276366168'}, {'name': 'Essam Abd El Mohsen', 'role': 'CONTACT', 'email': 'Essam_233@yahoo.com', 'phone': '201001971906'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahmoud Mohamed Fawzy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'resident doctor at health insurance hospital ,Assiut, Egypt', 'investigatorFullName': 'Mahmoud Mohamed Fawzy', 'investigatorAffiliation': 'Assiut University'}}}}