- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02372734
Long Term Cognitive Impact of Pediatric Acute Renal Injury
September 14, 2022 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
Recruiting
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 (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie-Carmelle Elie, MD
- Phone Number: 352-265-5911
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Recruiting
- UF Health
-
Contact:
- Marie-Carmelle Elie, MD
- Phone Number: 352-265-5911
- Email: elie@ufl.edu
-
Contact:
- Kristy L Radeker, MSM
- Phone Number: 352-733-1462
- Email: kristylp@ufl.edu
-
Principal Investigator:
- Marie-Carmelle Elie, MD
-
-
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
Genders Eligible for Study
All
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.
|
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.
|
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
Collaborators
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 (Anticipated)
April 15, 2025
Study Completion (Anticipated)
April 15, 2025
Study Registration Dates
First Submitted
February 20, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 26, 2015
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 14, 2022
Last Verified
September 1, 2022
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.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Ain Shams UniversityRecruiting
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on Pediatric Quality of Life (Peds QL) Survey
-
University Hospital, MontpellierPediatric and Congenital Cardiology Department of Necker-enfant malades University...CompletedQuality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years (QoL-CHD-5-7)Congenital Heart DiseaseFrance
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
Centre Hospitalier Universitaire de NiceCompletedEustachian Tube PatulousFrance
-
Washington University School of MedicineNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedQuality of Life | Surgical Procedure, UnspecifiedUnited States
-
McMaster UniversityNational Hemophilia Foundation; Patient Outcomes Research Group (PORG)RecruitingHemophilia | Chronic DiseaseCanada
-
McMaster UniversityNational Hemophilia FoundationCompleted
-
New York Medical CollegeTerminatedNecrotizing Soft Tissue InfectionUnited States
-
City of Hope Medical CenterActive, not recruitingLung Carcinoma | Colorectal Carcinoma | Pancreatic Carcinoma | Caregiver | Malignant Digestive System Neoplasm | Adult Liver CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant Solid Neoplasm | COVID-19 InfectionUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Portland VA Medical CenterCompletedDepression | Quality of Life | Pain | Physical Activity | Lung Cancer | Lung Cancer SymptomsUnited States