Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT06064305
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcriptional and Proteomic Analysis 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2023-09-01', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of transcriptional and proteomic gene regulation in tissue with clinical molecular Imaging and AKI biomarkers.', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Proteomic and RNAseq-based multi-omics pattern recognition.'}], 'secondaryOutcomes': [{'measure': 'Further organ failure based on systemic assessment', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Occurrence of organ failure based on hospital data including routinely applied scores, laboratory values or clinical examination.'}, {'measure': 'RRT incidence', 'timeFrame': '28 days', 'description': 'incidence of renal replacement therapy'}, {'measure': 'ICU length of stay', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Length of stay for ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Hospital length of stay'}, {'measure': 'Mortality', 'timeFrame': '28 day', 'description': '28 day mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury is associated with worsened outcome for critically ill patients. Sepsis-associated and non-septic cardiothoracic surgery associated AKI have been reported, nonetheless, precise pathomechanistic differences as well as detectability of transcriptional and proteomic changes in correlation with imaging and plasma markers are unclear.', 'detailedDescription': 'Acute kidney injury is a common and detrimental finding in critically ill/sepsis patients as well as non-septic patients post cardiothoracic surgery. In many cases renal replacement therapy is required and an acute kidney injury is linked to increased morbidity and mortality in intensive care patients. Using routinely obtained clinical samples as well as imaging data, this observational trial investigates the transcriptomic and proteomic determinants detectable in septic and non-septic AKI patient subsets and their correlation with outcome and AKI diagnostic parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '150 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AKI patients, nephrectomy patients', 'eligibilityCriteria': '* Inclusion criteria:\n\n * study consent;\n * KDIGO\\>=2;\n * vasoplegia and/or sepsis or elective nephrectomy.\n* Exclusion criteria:\n\n * Age\\<18 years;\n * pregnancy/nursing;\n * preexisting CKD with eGFR\\<60m/min;\n * dialysis; former ogran transplantation;\n * HIV; hematologic malignancies;\n * immunsuppression;\n * 4h post biopsy non-pausable effective anticoagulation;\n * pre-existing coagulopathy'}, 'identificationModule': {'nctId': 'NCT06064305', 'acronym': 'TPA-AKI', 'briefTitle': 'Transcriptional and Proteomic Analysis of Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Transcriptional and Proteomic Analysis of Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'AnIt22-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic AKI patients', 'description': 'Septic AKI patients', 'interventionNames': ['Other: No study-specific interventions']}, {'label': 'Non-septic post-cardiothoracic AKI patients', 'description': 'Non-septic post-cardiothoracic surgery AKI patients', 'interventionNames': ['Other: No study-specific interventions']}, {'label': 'non-AKI patients undergoing routine nephrectomy', 'description': 'non-AKI patients undergoing routine nephrectomy', 'interventionNames': ['Other: No study-specific interventions']}], 'interventions': [{'name': 'No study-specific interventions', 'type': 'OTHER', 'description': 'Septic AKI patients, post-cardiothoracic AKI patients and non-AKI patients undergoing routine nephrectomy. Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians and the respective specialists.', 'armGroupLabels': ['Non-septic post-cardiothoracic AKI patients', 'Septic AKI patients', 'non-AKI patients undergoing routine nephrectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alexander Zarbock, MD', 'role': 'CONTACT', 'email': 'zarbock@uni-muenster.de', 'phone': '+4925183', 'phoneExt': '47252'}, {'name': 'Andreas Margraf, MD', 'role': 'CONTACT', 'email': 'andreas.margraf@ukmuenster.de'}], 'overallOfficials': [{'name': 'Alexander Zarbock, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}