Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-01 @ 1:35 PM
Study NCT ID:
NCT01674660
Status:
UNKNOWN
Last Update Posted:
2012-08-31
First Post:
2012-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, white cells, urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-29', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interdialytic blood pressure', 'timeFrame': '44 hours', 'description': 'Ambulatory BP monitoring was performed after the midweek hemodialysis session for 44 hours. Ambulatory BPs were recorded every 20 minutes during the day (6 AM to 10 PM) and every 30 minutes during the night (10 PM to 6 AM) in the nonaccess arm, We use the coefficient of variation or standard deviation in interdialytic blood pressure as a indicator of systolic blood pressure variability.'}]}, 'conditionsModule': {'keywords': ['hemodialysis', 'blood pressure variability', 'volume status'], 'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.', 'detailedDescription': 'Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. However, additional unidentified risk factors also likely contribute to the disproportionately high prevalence of cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent one plausible cardiovascular risk factor. Data from nonuremic human populations show an association between greater blood pressure variability and cardiovascular events,nonfatal cardiovascular events,stroke,and increased left ventricular mass. There has been comparatively little work examining the causes and effects of blood pressure variability in hemodialysis populations. So the purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '24 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hemodialysis patients of Beijing Chaoyang Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* receipt of thrice-weekly in-center hemodialysis\n* no anticipation of imminent(\\<6 months)living related kidney transplant\n* not transfer of care to a nonparticipating facility\n* no dialytic modality change\n* free of vascular, infectious, or bleeding complication within 1 month Exclusion Criteria:\n* who missed \\>2 hemodialysis treatments over 1 month\n* abused drugs\n* severe anemia，malnutrition，chronic atrial fibrillation\n* body mass index of 40 \\>kg/m2'}, 'identificationModule': {'nctId': 'NCT01674660', 'briefTitle': 'Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'BeijingCYH'}, 'secondaryIdInfos': [{'id': '19860805', 'type': 'REGISTRY', 'domain': 'Ma Weihua'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'volume status', 'description': 'volume status:group1 over volume status,group2 normal volume status,group3 low volume status'}, {'label': 'night blood pressure', 'description': 'night blood pressure：group1 nondipper,group2 dipper,group3 extreme dipper,group4 riser'}, {'label': 'interdialysis weight gain', 'description': 'interdialysis weight gain:group1 \\>5% dry weight,group2 \\<5% dry weight'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Ma WH Weihua, Master', 'role': 'CONTACT', 'email': 'maweihua_521@sina.com', 'phone': '010-85231952'}, {'name': 'Cui TG taigen, Dr.', 'role': 'CONTACT', 'email': 'fujine_521@sina.com', 'phone': '010-85231952'}, {'name': 'Ma WH weihua, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nephrology, dialysis center,Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Cui TG Taigen, Dr.', 'role': 'CONTACT', 'email': 'fujine_521@sina.com', 'phone': '010-85231510'}, {'name': 'Ma WH Weihua, Master', 'role': 'CONTACT', 'email': 'maweihua_521@sina.com', 'phone': '010-85231952'}], 'overallOfficials': [{'name': 'Ma WH weihua, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigater', 'investigatorFullName': 'Ma Weihua', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}