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Completed

NCT Number: NCT02372734

Long Term Cognitive Impact of Pediatric Acute Renal Injury

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

2 year–36 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pediatric Quality of Life (Peds QL) Survey

Other

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.

Primary outcomes

  1. Overall health related quality of life score (HRQOL)

    Time frame: Baseline

    Scale 0-100

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • American Society of Nephrology

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2015
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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