Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06180551
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis
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': 'Plasma and urine samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary dickkopf-3', 'timeFrame': 'Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.', 'description': 'Urinary dickkopf-3'}, {'measure': 'Estimated Glomerula Filtration Rate', 'timeFrame': 'Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.', 'description': 'Estimated Glomerula Filtration Rate by CKD-EPI-formula.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.', 'description': 'Number of patients who die during the observational period.'}, {'measure': 'End Stage Renal Disease', 'timeFrame': 'Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.', 'description': 'Number of patients with initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation).'}, {'measure': 'Length of renal replacement therapy', 'timeFrame': 'During the ICU stay.', 'description': 'Length of time patients receive renal replacement therapy for chronic kidney injury.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Critically ill patients are at risk of developing a sudden decrease of kidney function which may be detected by a decrease in urine output or is diagnosed on the basis of blood tests for substances normally eliminated by the kidney, primarily creatinine.\n\nBecause it takes about 24 hours for the creatinine level to rise, even if both kidneys have ceased to function, better markers are needed.\n\nThis trial is investigating if the marker urinary dickkopf-3 (uDKK3) allows an early prediction of a sudden decrease of kidney function.', 'detailedDescription': 'Urinary dickkopf-3 (uDKK3), a stress-induced renal tubular epithelium-derived glycoprotein, has been identified as a biomarker predicting persistent kidney dysfunction.\n\nIn this prospective observational trial in patients at high risk of developing acute kidney injury we will assess whether urinary dickkopf-3 serves as a predictor of acute kidney injury.\n\nPatients of the intensive care units of Saarland University Hospital will be surveyed for up to two years after their admission to the intensive care unit.\n\nThe progression of the estimated Glomerular Filtration Rate and uDKK3 will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients on intensive care units of the Saarland University Hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated on the intensive care units of Saarland University Hospital.\n\nExclusion Criteria:\n\n* Patients on renal replacement treatment before admission to the intensive care unit.\n* Patients with chronic kidney disease stage CKD G3b or below.\n* Known kidney disease.\n* Kidney transplantation.\n* Intoxications leading to dialysis treatment.\n* Participation in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT06180551', 'acronym': 'RESCUE-AKI', 'briefTitle': 'Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis', 'orgStudyIdInfo': {'id': 'IMED IV-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DKK-3', 'type': 'DIAGNOSTIC_TEST', 'description': 'DKK-3-Urine measurement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Neuhaus, MD', 'role': 'CONTACT', 'email': 'stefan.neuhaus@uks.eu', 'phone': '+49684116', 'phoneExt': '15041'}], 'facility': 'Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'centralContacts': [{'name': 'Stefan Neuhaus, MD', 'role': 'CONTACT', 'email': 'stefan.neuhaus@uks.eu', 'phone': '+4968411615041'}], 'overallOfficials': [{'name': 'Stefan Neuhaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität des Saarlandes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}