Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-01 @ 7:12 PM
Study NCT ID:
NCT04241666
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonographic Examination of Renal Function in Individuals With Long-term Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'size of kidneys', 'timeFrame': 'at the time of inclusion into study', 'description': 'size of kidneys evaluated by sonography'}, {'measure': 'renal tissue echogenicity', 'timeFrame': 'at the time of inclusion into study', 'description': 'renal tissue echogenicity evaluated by sonography'}, {'measure': 'bladder evacuation method', 'timeFrame': 'at the time of inclusion into study', 'description': 'method of bladder evacuation'}, {'measure': 'lesion level', 'timeFrame': '1 year after spinal cord injury', 'description': 'highest intact spinal cord segment'}, {'measure': 'lesion severity', 'timeFrame': '1 year after spinal cord injury', 'description': 'severity of spinal cord injury according to American Spinal Injury Association Impairment Score (AIS) (A = motor and sensory complete, B = motor complete and sensory incomplete, C \\& D = motor and sensory incomplete, E = motor and sensory intact)'}, {'measure': 'duration of spinal cord injury', 'timeFrame': 'at the time of inclusion into study', 'description': 'time from spinal cord injury to inclusion into study (years)'}, {'measure': 'age', 'timeFrame': 'at the time of inclusion into study', 'description': 'time from birth to inclusion into study (years)'}], 'primaryOutcomes': [{'measure': 'renal clearance', 'timeFrame': 'at the time of inclusion into study', 'description': 'renal clearance of Technetium-99m-dimercaptosuccinic acid determined by scintigraphy'}], 'secondaryOutcomes': [{'measure': 'Cystatin C concentration', 'timeFrame': 'at the time of inclusion into study', 'description': 'blood serum concentration of Cystatin C (mg/L)'}, {'measure': 'Cystatin C clearance', 'timeFrame': 'at the time of inclusion into study', 'description': 'renal clearance of Cystatin C (ml/min) according to the Grubb formula'}, {'measure': 'renal peak systolic velocity', 'timeFrame': 'at the time of inclusion into study', 'description': 'Doppler sonography evaluation of renal blood flow during systolic heart phase (m/s)'}, {'measure': 'renal peak enddiastolic velocity', 'timeFrame': 'at the time of inclusion into study', 'description': 'Doppler sonography evaluation of renal blood flow during enddiastolic heart phase (m/s)'}, {'measure': 'renal resistive index', 'timeFrame': 'at the time of inclusion into study', 'description': '(systolic velocity - enddiastolic velocity) / systolic velocity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries', 'Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '41396487', 'type': 'DERIVED', 'citation': 'Jehli E, Krebs J, Schirp U, Walter MA, Wollner J, Pannek J. Decoding kidney function: evaluating arterial resistive index and cystatin C serum values in individuals with spinal cord injury. World J Urol. 2025 Dec 15;44(1):43. doi: 10.1007/s00345-025-06135-w.'}]}, 'descriptionModule': {'briefSummary': 'Patients with long-term lower urinary tract dysfunction due to spinal cord injury presenting for a routine urodynamic control will be screened for inclusion and exclusion criteria. Suitable individuals providing written informed consent will undergo renal Doppler sonography and renal scintigraphy in addition to the routine examinations. Conclusions regarding renal function based on the clearance rate determined by scintigraphy (gold standard) will be compared with the conclusions based on Doppler sonography and Cystatin C clearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals with long-term lower urinary tract dysfunction due to spinal cord injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* long-term spinal cord injury (≥10 years)\n* age ≥30 years\n* written informed consent\n\nExclusion Criteria:\n\n* dementia or severe intellectual impairment\n* serious internal illness\n* previous or current tumor disease\n* known allergy to the radioactive marker (Technetium)\n* pregnancy or breastfeeding\n* withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT04241666', 'briefTitle': 'Sonographic Examination of Renal Function in Individuals With Long-term Spinal Cord Injury', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Comparison of Sonographic Examination of Renal Function With Gold-standard Examination in Individuals With Long-term Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal renal function', 'description': 'individuals with renal clearance \\>89 ml/min/1.73m²', 'interventionNames': ['Diagnostic Test: renal scintigraphy', 'Diagnostic Test: renal doppler sonography']}, {'label': 'mild renal insufficiency', 'description': 'individuals with renal clearance 60-89 ml/min/1.73m²', 'interventionNames': ['Diagnostic Test: renal scintigraphy', 'Diagnostic Test: renal doppler sonography']}, {'label': 'moderate renal insufficiency', 'description': 'individuals with renal clearance 30-59 ml/min/1.73m²', 'interventionNames': ['Diagnostic Test: renal scintigraphy', 'Diagnostic Test: renal doppler sonography']}], 'interventions': [{'name': 'renal scintigraphy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys', 'armGroupLabels': ['mild renal insufficiency', 'moderate renal insufficiency', 'normal renal function']}, {'name': 'renal doppler sonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'doppler ultrasound of both kidneys', 'armGroupLabels': ['mild renal insufficiency', 'moderate renal insufficiency', 'normal renal function']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Jens Wöllner, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data will be made available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Lotte und Adolf Hotz-Sprenger Stiftung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}