Long Term Cognitive Impact of Pediatric Acute Renal Injury
1 other identifier
observational
73
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2024
CompletedJune 6, 2025
June 1, 2024
9.1 years
February 20, 2015
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall health related quality of life score (HRQOL)
Scale 0-100
Baseline
Study Arms (2)
Sepsis with acute kidney injury (AKI)
Prior admission for sepsis with a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey.
Sepsis without acute kidney injury (AKI)
Prior admission for sepsis without a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey.
Interventions
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.
Eligibility Criteria
Subjects are former patients admitted for sepsis as a child.
You may qualify if:
- Subjects may be adults or children who were admitted to the hospital with a severe infection between January 1998 to December 2014.
- Consent from adult or parent/guardian of child to participate in study.
- Assent from subjects between 7 and 17 years of age.
You may not qualify if:
- Failure or inability to complete the survey
- Participant is unable to understand written or spoken English
- Subjects between 7 and 17 years of age unwilling to assent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- American Society of Nephrologycollaborator
Study Sites (1)
UF Health
Gainesville, Florida, 32608, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Carmelle Elie, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2015
First Posted
February 26, 2015
Study Start
June 1, 2015
Primary Completion
June 26, 2024
Study Completion
June 26, 2024
Last Updated
June 6, 2025
Record last verified: 2024-06