Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-28 @ 9:05 PM
Study NCT ID:
NCT02372734
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Cognitive Impact of Pediatric Acute Renal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall health related quality of life score (HRQOL)', 'timeFrame': 'Baseline', 'description': 'Scale 0-100'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The research study will investigate the longitudinal cognitive outcomes in subjects admitted as children diagnosed with sepsis who may have had acute kidney injury. Each subject will be contacted 2-15 years after their incident admission in order to solicit responses to a functional and cognitive quality of life survey. Children admitted during the same time frame that did not have kidney injury will also be surveyed.', 'detailedDescription': '250 subjects with a prior admission for pediatric sepsis will be contacted 2-15 years following the incident admission in order to complete a survey to assess their overall quality of life. Children will be administered the Pediatric Quality of Life (PedsQL) survey with a parental section to allow for parental response. Adult subjects will take the adult version of the PedsQL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are former patients admitted for sepsis as a child.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects may be adults or children who were admitted to the hospital with a severe infection between January 1998 to December 2014.\n* Consent from adult or parent/guardian of child to participate in study.\n* Assent from subjects between 7 and 17 years of age.\n\nExclusion Criteria:\n\n* Failure or inability to complete the survey\n* Participant is unable to understand written or spoken English\n* Subjects between 7 and 17 years of age unwilling to assent.'}, 'identificationModule': {'nctId': 'NCT02372734', 'briefTitle': 'Long Term Cognitive Impact of Pediatric Acute Renal Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Long Term Cognitive Impact of Pediatric Acute Renal Injury', 'orgStudyIdInfo': {'id': 'IRB201401054'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis with acute kidney injury (AKI)', 'description': 'Prior admission for sepsis with a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey.', 'interventionNames': ['Other: Pediatric Quality of Life (Peds QL) Survey']}, {'label': 'Sepsis without acute kidney injury (AKI)', 'description': 'Prior admission for sepsis without a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey.', 'interventionNames': ['Other: Pediatric Quality of Life (Peds QL) Survey']}], 'interventions': [{'name': 'Pediatric Quality of Life (Peds QL) Survey', 'type': 'OTHER', 'description': 'The subjects will be administered the Peds QL survey. Children will also have a parental section for parental response. This is NOT an interventional study.', 'armGroupLabels': ['Sepsis with acute kidney injury (AKI)', 'Sepsis without acute kidney injury (AKI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Marie-Carmelle Elie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society of Nephrology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}