Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-02 @ 9:50 AM
Study NCT ID:
NCT05114057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-12
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], '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'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1380}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Decision Support Performance', 'timeFrame': 'Days 2-4 after ICU admission', 'description': 'Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV)'}], 'secondaryOutcomes': [{'measure': 'Rate of Clinical Decision Support Completion', 'timeFrame': '48 hours', 'description': 'Time to complete the risk stratification and biomarker testing is less than 48 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Angina Index', 'NGAL'], 'conditions': ['Acute Kidney Injury', 'Acute Kidney Injury Due to Sepsis', 'Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.', 'detailedDescription': 'In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution\n\nExclusion Criteria:\n\n* Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \\<60 mL/min/1.736m2)\n* History of kidney transplant within the previous 90 days\n* Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission\n* Acute DNR order or clinical team is not committed to escalating medical care\n* Anticipated to require intensive care for less than 48 hours'}, 'identificationModule': {'nctId': 'NCT05114057', 'acronym': 'Taking Focus 2', 'briefTitle': 'Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates with Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'CIN002 - Taking Focus 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PICU Patients', 'description': 'Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.', 'interventionNames': ['Other: Renal Angina Index (RAI)']}, {'type': 'OTHER', 'label': 'CICU Patients', 'description': 'Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass', 'interventionNames': ['Other: Renal Angina Index (RAI)']}, {'type': 'OTHER', 'label': 'NICU Patients', 'description': 'Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries', 'interventionNames': ['Other: Renal Angina Index (RAI)']}], 'interventions': [{'name': 'Renal Angina Index (RAI)', 'type': 'OTHER', 'description': 'Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury', 'armGroupLabels': ['CICU Patients', 'NICU Patients', 'PICU Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Kelli A Krallman, RN, BSN, MS', 'role': 'CONTACT', 'email': 'kelli.krallman@cchmc.org'}, {'name': 'Stuart L Goldstein, MD', 'role': 'CONTACT'}, {'name': 'Katja Gist, DO', 'role': 'CONTACT'}, {'name': 'Cara Slagle, MD', 'role': 'CONTACT'}, {'name': 'Natalja Stanski, MD', 'role': 'CONTACT'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Kelli A Krallman, RN, BSN, MS', 'role': 'CONTACT', 'email': 'kelli.krallman@cchmc.org', 'phone': '513-636-4837'}], 'overallOfficials': [{'name': 'Stuart L Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}