Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT00743106
Status:
TERMINATED
Last Update Posted:
2018-09-19
First Post:
2008-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018818', 'term': 'Fenoldopam'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oharaj@ccf.org', 'phone': '216-444-8278', 'title': "Jerome O'Hara, MD", 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours\n\nPlacebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fenoldopam', 'description': 'Fenoldopam (0.1 \\~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.\n\nFenoldopam: Fenoldopam (0.1 \\~g/kg/min)started during surgery and lasting for a total of 24 hours', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glomerular Filtration Rate (GFR) Percentage of Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours\n\nPlacebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery'}, {'id': 'OG001', 'title': 'Fenoldopam', 'description': 'Fenoldopam (0.1 \\~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.\n\nFenoldopam: Fenoldopam (0.1 \\~g/kg/min)started during surgery and lasting for a total of 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-39', 'spread': '28', 'groupId': 'OG000'}, {'value': '-28', 'spread': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-31', 'ciUpperLimit': '9', 'estimateComment': 'The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'percentage of change from baseline to post-operatively day 3', 'description': 'Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Creatinine (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours\n\nPlacebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery'}, {'id': 'OG001', 'title': 'Fenoldopam', 'description': 'Fenoldopam (0.1 \\~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.\n\nFenoldopam: Fenoldopam (0.1 \\~g/kg/min)started during surgery and lasting for a total of 24 hours'}], 'classes': [{'title': 'immediately postoperative', 'categories': [{'measurements': [{'value': '1.44', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 1', 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 2', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 3', 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 4', 'categories': [{'measurements': [{'value': '2.76', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.19', 'groupDescription': 'We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '"immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"', 'description': 'assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours\n\nPlacebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery'}, {'id': 'FG001', 'title': 'Fenoldopam', 'description': 'Fenoldopam (0.1 \\~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.\n\nFenoldopam: Fenoldopam (0.1 \\~g/kg/min)started during surgery and lasting for a total of 24 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Met intraoperative exclusion criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours\n\nPlacebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery'}, {'id': 'BG001', 'title': 'Fenoldopam', 'description': 'Fenoldopam (0.1 \\~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.\n\nFenoldopam: Fenoldopam (0.1 \\~g/kg/min)started during surgery and lasting for a total of 24 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '9', 'groupId': 'BG000'}, {'value': '59', 'spread': '10', 'groupId': 'BG001'}, {'value': '59', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'GFR', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '19', 'groupId': 'BG000'}, {'value': '59', 'spread': '19', 'groupId': 'BG001'}, {'value': '59', 'spread': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'creatinine', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '1.4'}, {'value': '1.2', 'groupId': 'BG001', 'lowerLimit': '1.0', 'upperLimit': '1.4'}, {'value': '1.2', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'Executive committee determined to close study after interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2008-08-26', 'resultsFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-13', 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular Filtration Rate (GFR) Percentage of Change From Baseline', 'timeFrame': 'percentage of change from baseline to post-operatively day 3', 'description': 'Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Creatinine (mg/dL)', 'timeFrame': '"immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"', 'description': 'assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nephrectomy', 'fenoldopam', 'atrophic minimally functioning kidney'], 'conditions': ['Partial Nephrectomy']}, 'referencesModule': {'references': [{'pmid': '39607014', 'type': 'DERIVED', 'citation': 'Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.\n\nThe investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.', 'detailedDescription': 'Prospective, randomized, blinded study-dividing patients into one of two groups: fenoldopam or placebo. The infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.Study time period will be approximately six weeks from the date of surgery. Specifically, the following pre- and post operative laboratory results will be recorded if available: . Basic metabolic panel - pre-op, post op days 1, 2, 3, 4, and 6 weeks\n\n* Serum osmolality, urine osmolality, urine sodium - pre-op, post op days 1, 3\n* Glomerular filtration rate - pre-op, post op days 1, 3, and 6 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have a solitary kidney and present for a partial nephrectomy\n* Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney\n\nExclusion Criteria:\n\n* History of current renal disease beyond the diagnosis of renal malignancy\n* Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty\n* History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected\n* A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics'}, 'identificationModule': {'nctId': 'NCT00743106', 'briefTitle': 'The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery', 'orgStudyIdInfo': {'id': '5508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fenoldopam Comparator', 'description': 'Fenoldopam (0.1 \\~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.', 'interventionNames': ['Drug: Fenoldopam']}], 'interventions': [{'name': 'Fenoldopam', 'type': 'DRUG', 'description': 'Fenoldopam (0.1 \\~g/kg/min)started during surgery and lasting for a total of 24 hours', 'armGroupLabels': ['Fenoldopam Comparator']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clnic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': "Jerome O'Hara, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Daniel I Sessler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cleveland Clnic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}