Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-04-21 @ 8:38 PM
Study NCT ID:
NCT02929160
Status:
WITHDRAWN
Last Update Posted:
2022-09-27
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Nephrostomy Versus Stent In Sepsis Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D006869', 'term': 'Hydronephrosis'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009403', 'term': 'Nephrostomy, Percutaneous'}], 'ancestors': [{'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074643', 'term': 'Nephrotomy'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D014547', 'term': 'Urinary Diversion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-24', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to normalisation of white cell count and/or temperature', 'timeFrame': 'Within 1 week'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Within 1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ureteric Calculus', 'Sepsis', 'Hydronephrosis']}, 'descriptionModule': {'briefSummary': 'Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.', 'detailedDescription': 'The obstructed kidney in the setting of urosepsis is a urological emergency. Stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. Therefore, urgent decompression of the collecting system is warranted.\n\nThere are two options for urgent decompression of an obstructed collecting system:\n\n1. Image-guided percutaneous nephrostomy tube placement\n2. Cystoscopic retrograde placement of a ureteric stent\n\nThis strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.\n\nBoth the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.\n\nThis study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ureteric calculus with proximal hydronephrosis confirmed on CT KUB\n* White cell count \\>12,000mm3 and/or temperature \\>38C\n\nExclusion Criteria:\n\n* Uncorrected coagulopathy\n* Urethral or ureteric stricture disease\n* Urinary diversion\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02929160', 'acronym': 'PERSIST', 'briefTitle': 'Percutaneous Nephrostomy Versus Stent In Sepsis Trial', 'organization': {'class': 'OTHER', 'fullName': "The Adelaide and Meath Hospital, incorporating The National Children's Hospital"}, 'officialTitle': 'Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial', 'orgStudyIdInfo': {'id': 'AMNCH-GU-2016-1'}, 'secondaryIdInfos': [{'id': '2016-004022-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCN', 'description': 'Percutaneous nephrostomy', 'interventionNames': ['Procedure: Percutaneous nephrostomy']}, {'type': 'EXPERIMENTAL', 'label': 'JJ Stent', 'description': 'Retrograde ureteric JJ stent', 'interventionNames': ['Procedure: Retrograde ureteric JJ stent']}], 'interventions': [{'name': 'Percutaneous nephrostomy', 'type': 'PROCEDURE', 'description': 'Percutaneous nephrostomy tube insertion under radiological guidance', 'armGroupLabels': ['PCN']}, {'name': 'Retrograde ureteric JJ stent', 'type': 'PROCEDURE', 'description': 'Retrograde ureteric JJ stent insertion using cystoscopy', 'armGroupLabels': ['JJ Stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tallaght', 'state': 'Dublin', 'country': 'Ireland', 'facility': "The Adelaide and Meath Hospital, incorporating The National Children's Hospital", 'geoPoint': {'lat': 53.2859, 'lon': -6.37344}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St. James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Adelaide and Meath Hospital, incorporating The National Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Urologist', 'investigatorFullName': 'Rustom P Manecksha, MD, FRCS (Urol.)', 'investigatorAffiliation': "The Adelaide and Meath Hospital, incorporating The National Children's Hospital"}}}}