Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-26 @ 5:14 AM
Study NCT ID:
NCT04162834
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2019-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Papaverine on Renal Artery Blood Flow Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010208', 'term': 'Papaverine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal artery blood flow', 'timeFrame': 'at 2 minutes after papaverine administration', 'description': 'Renal artery blood flow 2 minutes after papaverine administration by doppler sonography'}], 'secondaryOutcomes': [{'measure': 'estimated glomerular filtration rate', 'timeFrame': 'at postoperative day 0', 'description': 'estimated glomerular filtration rate using KIDGO equation'}, {'measure': 'estimated glomerular filtration rate', 'timeFrame': 'at postoperative day 1', 'description': 'estimated glomerular filtration rate using KIDGO equation'}, {'measure': 'estimated glomerular filtration rate', 'timeFrame': 'at postoperative day 4', 'description': 'estimated glomerular filtration rate using KIDGO equation'}, {'measure': 'estimated glomerular filtration rate', 'timeFrame': 'at postoperative day 14', 'description': 'estimated glomerular filtration rate using KIDGO equation'}, {'measure': 'estimated glomerular filtration rate', 'timeFrame': 'at postoperative month 3', 'description': 'estimated glomerular filtration rate using KIDGO equation'}, {'measure': 'glomerular filtration rate using renal scan', 'timeFrame': 'at postoperative month 3', 'description': 'glomerular filtration rate using renal scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery.', 'detailedDescription': 'The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with kidney cancer.\n* Patients undergoing robot assisted partial nephrectomy under general anesthesia\n* 20 years old ≤ age \\<80 years old\n* Patients who voluntarily agreed to this clinical study\n* eGFR ≥ 60 ml / min / 1.73 m2 (Chronic Kidney Disease Epidemiology Patients with Collaboration)\n\nExclusion Criteria:\n\n* The tumor ≥ 7 cm in size\n* Multiple renal mass\n* If the surgery plan is changed due to open\n* When surgery is performed together with other surgery\n* Multiple renal artery\n* Patients with hypersensitivity to papaverine\n* Patients with atrioventricular block\n* Pregnant and lactating women\n* Patients using levodopa\n* Refusal of patient'}, 'identificationModule': {'nctId': 'NCT04162834', 'briefTitle': 'Effect of Papaverine on Renal Artery Blood Flow Volume', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study', 'orgStudyIdInfo': {'id': '20191111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Papaverine group', 'description': 'Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.', 'interventionNames': ['Drug: Papaverine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal saline group', 'description': 'Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Papaverine', 'type': 'DRUG', 'description': 'Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.', 'armGroupLabels': ['Papaverine group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.', 'armGroupLabels': ['Normal saline group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Kug Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Young-Kug Kim, MD', 'investigatorAffiliation': 'Asan Medical Center'}}}}