Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT02390193
Status:
UNKNOWN
Last Update Posted:
2018-06-15
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006435', 'term': 'Renal Dialysis'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collapsibility of the upper airway.', 'timeFrame': '06 months', 'description': 'Degree of upper airway collapsibility through the negative expiratory pressure test in patients with chronic kidney disease on hemodialysis.'}], 'secondaryOutcomes': [{'measure': 'Prevalence and severity of sleep disorders', 'timeFrame': '06 months', 'description': 'To assess the effects of dialysis on sleep parameters and determine the prevalence and severity of sleep disorders.'}, {'measure': 'Change in pulmonary function.', 'timeFrame': '06 months', 'description': 'Lung function tests will be performed during the day, with the patient seated in a comfortable position. For such, the KoKo PFT Spirometer System version 4.11 (nSpire Health, Inc, Louisville, CO, USA) will be used in accordance with the guidelines for the execution of lung function tests established by the Brazilian Society of Pneumology and European Respiratory Society.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Dialysis', 'Sleep', 'Pulmonary function', 'Polysomnography', 'Upper airway'], 'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': 'Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public health problems, becoming a global epidemic. It is also known that the amount of displacement of overnight rostral fluid, from the lower limbs, is related to increased neck circumference and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease. Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the negative expiratory pressure and nocturnal polysomnography will be performed before and after the hemodialysis session. Discussion: The incidence of CKD has increased, due to the increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the weight gain due to volume overload, observed in the interdialytic period, will exert a negative influence on the degree of collapsibility of the upper airways predispose to OSA in CKD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients aged 18 to 80 years;\n* chronic kidney failure;\n* candidate for kidney transplant with indication for dialysis;\n* cognitive level sufficient for understanding the procedures and following the instructions;\n* absence of dementia or treatment-refractory psychiatric diseases leading to an inability to provide informed consent.\n* and agreement to participate by signing a statement of informed consent.\n\nExclusion Criteria:\n\n* craniofacial abnormalities;\n* undergoing active treatment of sleep apnea;\n* active malignancy;\n* active alcohol and/or drug abuse;'}, 'identificationModule': {'nctId': 'NCT02390193', 'briefTitle': 'Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitário de Anapolis'}, 'officialTitle': 'Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '368856/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hemodialysis', 'description': 'Chronic kidney disease patients undergoing hemodialysis will be recruited consecutively and screened for eligibility using a standardised protocol.', 'interventionNames': ['Procedure: Hemodialysis']}], 'interventions': [{'name': 'Hemodialysis', 'type': 'PROCEDURE', 'description': 'Daytime haemodialysis was standardised. It was performed 3 times per week, with a 4-h session duration, 250-mL/min blood flow, and 500-mL/min dialysate flow, using bicarbonate buffered dialysate with 1.25 mmol/L ionised calcium concentration, dialysate temperature of 36.5°C.\n\nThe ultrafiltration amount for each haemodialysis session was decided by individual dry weight, which was fixed during the trial. In addition, the patients were not permitted to change their medication or start new drugs, especially antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, and β-blockers.\n\nThe patients who required a change in medication for medical reasons were subsequently excluded from the study.', 'armGroupLabels': ['Hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75083-515', 'city': 'Anápolis', 'state': 'Goiás', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Luis VF Oliveira, PhD', 'role': 'CONTACT', 'email': 'oliveira.lvf@gmail.com', 'phone': '+55 62 33106600', 'phoneExt': '6717'}], 'facility': 'Centro Universitário de Anápolis - UniEVANGÉLICA', 'geoPoint': {'lat': -16.32667, 'lon': -48.95278}}], 'centralContacts': [{'name': 'Luis VF Oliveira, PhD', 'role': 'CONTACT', 'email': 'oliveira.lvf@pq.cnpq.br', 'phone': '+55 62 999052309'}], 'overallOfficials': [{'name': 'Luis VF Oliveira, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro Universitário de Anápolis - UniEVANGÉLICA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitário de Anapolis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Irmandade da Santa Casa de Misericordia de Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Luis Vicente Franco de Oliveira', 'investigatorAffiliation': 'Centro Universitário de Anapolis'}}}}