Long Term Cognitive Impact of Pediatric Acute Renal Injury

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02372734
• Collaborator: American Society of Nephrology (Other)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 82
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Other: Pediatric Quality of Life (Peds QL) Survey

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
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Long Term Cognitive Impact of Pediatric Acute Renal Injury
• Actual Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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

   Scale 0-100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 36 Years
• Sexes Eligible for Study: 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Health	Gainesville	Florida	United States	32608

Sponsors and Collaborators

• University of Florida
• American Society of Nephrology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02372734
• Other Study ID Numbers: IRB201401054
• First Posted: Feb 26, 2015
• Last Update Posted: Jun 7, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Jun 7, 2021