Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-27 @ 4:08 AM
Study NCT ID:
NCT03236103
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2017-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label single group interventional study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of AKI in hospitalized VAD patients based on AKIN criteria', 'timeFrame': 'The first 7 days of hospitalization', 'description': 'The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output \\<0.5 ml/kg/h for 6 h; 2) serum creatinine increase \\> 2.0-3.0 fold from baseline OR urine output \\<0.5 ml/kg/h for 12 h; 3) serum creatinine increase \\>3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output \\<0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT'}, {'measure': 'Severity of AKI based on AKIN stages (I, II, III) 1', 'timeFrame': 'The first 7 days of the hospitalization', 'description': 'The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output \\<0.5 ml/kg/h for 6 h; 2) serum creatinine increase \\> 2.0-3.0 fold from baseline OR urine output \\<0.5 ml/kg/h for 12 h; 3) serum creatinine increase \\>3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output \\<0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'One year after hospitalization', 'description': 'The length of hospital stay will be determined from the electronic medical record.'}, {'measure': 'In hospital, 60 day and one-year mortality', 'timeFrame': 'One year after enrollment', 'description': 'The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventricular assist device'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications', 'detailedDescription': "The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications\n\nParticipants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice.\n\nIf the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge.\n\nThe investigators will review the participant's medical record up to one year after surgery.\n\nThis study will not include any experimental laboratory tests or experimental medication.\n\nThe clinical recommendations will regard the following:\n\n1. Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)\n2. Optimizing volume status (avoidance of volume overload or depletion)\n3. Optimizing electrolytes and acid-base status\n4. Optimizing hemodynamics (Mean arterial BP\\>65mmHg)\n5. Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.\n\nThe investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAdult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied.\n\nPatients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient.\n\nExclusion criteria:\n\nPatients on dialysis (hemodialysis or peritoneal dialysis).'}, 'identificationModule': {'nctId': 'NCT03236103', 'briefTitle': 'AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.', 'orgStudyIdInfo': {'id': '17-002670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subjects with VAD in place', 'description': "Adult patients with VAD in place who are admitted to the hospital for acute medical illness. The investigators will provide clinical recommendations to the subject's primary care provider.", 'interventionNames': ['Other: Clinical Recommendations']}], 'interventions': [{'name': 'Clinical Recommendations', 'type': 'OTHER', 'description': 'The clinical recommendations will regard the following:\n\n1. Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)\n2. Optimizing volume status (avoidance of volume overload or depletion)\n3. Optimizing electrolytes and acid-base status\n4. Optimizing hemodynamics (Mean arterial BP\\>65mmHg)\n5. Assessment of kidney function with serum creatinine and/or cystatin C\n\nNone of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.', 'armGroupLabels': ['Subjects with VAD in place']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Qi Qian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qi Qian, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}