Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 8:00 PM
Study NCT ID:
NCT05035303
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2021-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double- blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemoglobin drop', 'timeFrame': '72 hours post intervention', 'description': 'the lower drop is better'}, {'measure': 'blood loss', 'timeFrame': 'immediately after surgery', 'description': 'the lower loss is better'}], 'secondaryOutcomes': [{'measure': 'stone free rate', 'timeFrame': 'within 3 months post-operative', 'description': 'the higher is better'}, {'measure': 'adverse events', 'timeFrame': 'within 30 days post-operative', 'description': 'the lower is better'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Loss, Surgical']}, 'descriptionModule': {'briefSummary': 'during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change \\& blood loss is estimated and will compared.', 'detailedDescription': 'All patients of are positioned in lithotomy position and 6 F open tip ureteral catheter is fixed by cystoscope. Then, A pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 Gauge (G) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 G Chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an Amplatz sheath was inserted.\n\nnephroscope is used for stones disintegration by pneumatic or laser lithotripter . Fragments are washed out or removed by forceps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* renal stones\\>2 cm\n\nExclusion Criteria:\n\n* coagulopathy, congenital anomalies, active Urinary tract infections'}, 'identificationModule': {'nctId': 'NCT05035303', 'briefTitle': 'Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study.', 'orgStudyIdInfo': {'id': 'RC-200310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nor-Epinephrine (NE)-Group', 'description': 'The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.', 'interventionNames': ['Procedure: Nor-Epinephrine injection versus saline during PCNL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'S-Group', 'description': 'The PCNL tract is infiltrated by Normal Saline before its dilatation.', 'interventionNames': ['Procedure: Nor-Epinephrine injection versus saline during PCNL']}], 'interventions': [{'name': 'Nor-Epinephrine injection versus saline during PCNL', 'type': 'PROCEDURE', 'description': 'The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.', 'armGroupLabels': ['Nor-Epinephrine (NE)-Group', 'S-Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13518', 'city': 'Banhā', 'state': 'Kalubiaya', 'country': 'Egypt', 'facility': 'Banha University Hospitals', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}, {'zip': '13511', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'Banha university hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Waleed El-Shaer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Banha university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Waleed El-Shaer, MD', 'investigatorAffiliation': 'Benha University'}}}}