Long Term Cognitive Impact of Pediatric Acute Renal Injury

NCT ID: NCT02372734

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2024-06-26

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Pediatric Quality of Life (Peds QL) Survey

Intervention Type: 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.

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.

Pediatric Quality of Life (Peds QL) Survey

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Nephrology

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Carmelle Elie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201401054

Identifier Type: -

Identifier Source: org_study_id