Long Term Cognitive Impact of Pediatric Acute Renal Injury

Active, not recruiting

• Conditions: Acute Kidney Injury
• Interventions: Other: Pediatric Quality of Life (Peds QL) Survey

• Registration Number: NCT02372734
• Lead Sponsor: University of Florida

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 Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Study Start: 2015-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis with acute kidney injury (AKI)	Pediatric Quality of Life (Peds QL) Survey	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)	Pediatric Quality of Life (Peds QL) Survey	Prior admission for sepsis without a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey.

Primary Outcome Measures

Name	Time	Method
Overall health related quality of life score (HRQOL)	Baseline	Scale 0-100

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States