Long Term Cognitive Impact of Pediatric Acute Renal Injury

June 3, 2025 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 36 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects are former patients admitted for sepsis as a child.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall health related quality of life score (HRQOL)
Time Frame: Baseline
Scale 0-100
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

American Society of Nephrology

Investigators

  • Principal Investigator: Marie-Carmelle Elie, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

June 26, 2024

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimated)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201401054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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