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Clinical Trials/NCT02372734
NCT02372734CompletedNot Applicable

Long Term Cognitive Impact of Pediatric Acute Renal Injury

University of Florida1 site in 1 country73 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
73
Locations
1
Primary Endpoint
Overall health related quality of life score (HRQOL)

Study Overview

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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
2 Years to 36 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects may be adults or children who were admitted to the hospital with a severe infection between January 1998 to December
  • 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.

Outcomes

Primary Outcomes

Overall health related quality of life score (HRQOL)

Time Frame: Baseline

Scale 0-100

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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