Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-04 @ 5:58 AM
Study NCT ID:
NCT01859260
Status:
WITHDRAWN
Last Update Posted:
2019-04-29
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized 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'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute kidney injury', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'incidence of acute kidney injury during hospitalization (defined as an increase in creatinine by 0.5 mg/dl or more)'}], 'secondaryOutcomes': [{'measure': 'Nocturnal hypoxia', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Nocturnal hypoxia, defined as oxygen saturation \\< 88%'}, {'measure': 'Blood pressure control', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Blood pressure control, defined as incidence of SBP \\> 160'}, {'measure': 'Hospital length of stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Hospital length of stay'}, {'measure': 'composite outcome', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Composite outcome of a) Incidence of major cardiovascular event (acute coronary syndrome, major arrhythmia, or exacerbation of CHF), b) Initiation of hemodialysis c)In-hospital mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic kidney disease, acute kidney injury, obstructive sleep apnea'], 'conditions': ['Chronic Kidney Disease', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '21369754', 'type': 'BACKGROUND', 'citation': 'Kanbay A, Buyukoglan H, Ozdogan N, Kaya E, Oymak FS, Gulmez I, Demir R, Kokturk O, Covic A. Obstructive sleep apnea syndrome is related to the progression of chronic kidney disease. Int Urol Nephrol. 2012 Apr;44(2):535-9. doi: 10.1007/s11255-011-9927-8. Epub 2011 Mar 3.'}, {'pmid': '11729258', 'type': 'BACKGROUND', 'citation': 'Zoccali C, Mallamaci F, Tripepi G. Sleep apnea in renal patients. J Am Soc Nephrol. 2001 Dec;12(12):2854-2859. doi: 10.1681/ASN.V12122854. No abstract available.'}, {'pmid': '8305638', 'type': 'BACKGROUND', 'citation': 'Fletcher EC. Obstructive sleep apnea and the kidney. J Am Soc Nephrol. 1993 Nov;4(5):1111-21. doi: 10.1681/ASN.V451111.'}, {'pmid': '18633339', 'type': 'BACKGROUND', 'citation': 'Fine LG, Norman JT. Chronic hypoxia as a mechanism of progression of chronic kidney diseases: from hypothesis to novel therapeutics. Kidney Int. 2008 Oct;74(7):867-72. doi: 10.1038/ki.2008.350. Epub 2008 Jul 16.'}, {'pmid': '22222188', 'type': 'BACKGROUND', 'citation': 'Nicholl DDM, Ahmed SB, Loewen AHS, Hemmelgarn BR, Sola DY, Beecroft JM, Turin TC, Hanly PJ. Declining kidney function increases the prevalence of sleep apnea and nocturnal hypoxia. Chest. 2012 Jun;141(6):1422-1430. doi: 10.1378/chest.11-1809. Epub 2012 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA is associated with worsening kidney function. Hospitalized patients are often exposed to multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which place them at risk for acute worsening of kidney function. This study aims to determine whether immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence of acute kidney injury during hospitalization. The investigators will evaluate the extent to which this effect can be attributed to a decrease in nocturnal hypoxia and improved blood pressure control. Secondary endpoints include hospital length of stay, and a composite outcome comprised of hemodialysis initiation, major cardiovascular events, and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CKD defined by National Kidney Foundation Staging system: eGFR \\< 60\n2. Overnight sleep study consistent with OSA\n\nExclusion Criteria:\n\n1. Currently treated with positive airway pressure for sleep-disordered breathing\n2. Hemodynamically unstable, defined as SBP \\< 90, or use of vasopressors\n3. Intubated or mechanically ventilated\n4. Respiratory insufficiency, defined as P/F ratio \\< 250, or requiring mechanical ventilation\n5. End stage renal disease on renal replacement therapy\n6. Contraindication to CPAP, including active emesis, recent intracranial surgery, altered level of consciousness'}, 'identificationModule': {'nctId': 'NCT01859260', 'briefTitle': 'Using Continuous Positive Airway Pressure to Reduce the Incidence of Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Using CPAP to Prevent Acute Kidney Injury in Hospitalized Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'TGHCPAPCKD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'CPAP/autopap', 'interventionNames': ['Device: CPAP/autopap']}], 'interventions': [{'name': 'CPAP/autopap', 'type': 'DEVICE', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa general hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}