Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-26 @ 5:00 AM
Study NCT ID:
NCT05648435
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lithium Clearance in Patients With High Risk of Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-05', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal lithium clearance', 'timeFrame': 'Repeated measures between 07:00-20:00', 'description': 'Measurement of renal lithium clearance at 8AM, 2 PM, and 8 PM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function.\n\nIn this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls.', 'detailedDescription': 'Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS). The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular injury, will be measured by a spectrophotometric method using a commercially available kit. Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory, University Hospital of North Norway, Tromsø.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care patients and healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria sepsis associated acute kidney injury:\n\n* Sepsis diagnosed or suspected\n* Age \\>18 years\n\nInclusion Criteria healthy controls:\n\n* Previously healthy individuals\n* Age \\>18 years\n\nExclusion Criteria:\n\nOliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT05648435', 'briefTitle': 'Lithium Clearance in Patients With High Risk of Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Proximal Tubule Function in Septic Patients as Measured by Endogenous Lithium Clearance', 'orgStudyIdInfo': {'id': 'REK 536547'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis patients', 'description': 'No interventions', 'interventionNames': ['Diagnostic Test: Lithium measures']}, {'label': 'Healthy controls', 'description': 'No interventions', 'interventionNames': ['Diagnostic Test: Lithium measures']}], 'interventions': [{'name': 'Lithium measures', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurements of lithium levels in blood and urine', 'armGroupLabels': ['Healthy controls', 'Sepsis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'state': 'Troms', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}