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NCT02372734 Clinical Trial

Long Term Cognitive Impact of Pediatric Acute Renal Injury

Acute Kidney Injury Clinical Trial

Official title:
Long Term Cognitive Impact of Pediatric Acute Renal Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02372734
Other study ID # IRB201401054
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2015
Est. completion date April 15, 2025

Study information
Verified date June 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date April 15, 2025
Est. primary completion date April 15, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 36 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pediatric Quality of Life (Peds QL) Survey
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.

Locations
Country Name City State
United States UF Health Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida American Society of Nephrology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall health related quality of life score (HRQOL) Scale 0-100 Baseline
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