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Long Term Cognitive Impact of Pediatric Acute Renal Injury

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ClinicalTrials.gov Identifier: NCT02372734
Recruitment Status : Recruiting
First Posted : February 26, 2015
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
American Society of Nephrology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : June 2015
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

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.




Primary Outcome Measures :
  1. Overall health related quality of life score (HRQOL) [ Time Frame: Baseline ]
    Scale 0-100



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 36 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects are former patients admitted for sepsis as a child.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372734


Contacts
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Contact: Marie-Carmelle Elie, MD 352-265-5911

Locations
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United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32608
Contact: Marie-Carmelle Elie, MD    352-265-5911    elie@ufl.edu   
Contact: Kristy L Radeker, MSM    352-733-1462    kristylp@ufl.edu   
Principal Investigator: Marie-Carmelle Elie, MD         
Sponsors and Collaborators
University of Florida
American Society of Nephrology
Investigators
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Principal Investigator: Marie-Carmelle Elie, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02372734    
Other Study ID Numbers: IRB201401054
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases