Acute Kidney InjuryNCT02372734
Long Term Cognitive Impact of Pediatric Acute Renal Injury
An observational study of Acute Kidney Injury, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 36 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Pediatric Quality of Life (Peds QL) Survey
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 26 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects are former patients admitted for sepsis as a child.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Pediatric Quality of Life (Peds QL) Survey
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Quality of Life (Peds QL) SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pediatric Quality of Life (Peds QL) Survey | |
| 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. Receives: Other: Pediatric Quality of Life (Peds QL) Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall health related quality of life score (HRQOL)
Scale 0-100
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJun 2015
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Nephrology
- Responsible party
- Sponsor
- Investigators
- Marie-Carmelle Elie, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372734
- Sponsor's protocol ID
- IRB201401054
- Status last verified
- Jun 2024
- First submitted
- 20 Feb 2015
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Cognitive Impact of Pediatric Acute Renal Injury
- ClinicalTrials.gov ID
- NCT02372734
- Acronym / sponsor ID
- IRB201401054
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Society of Nephrology
- Study start
- Jun 2015 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis with acute kidney injury (AKI) | – | Other: Pediatric Quality of Life (Peds QL) SurveyPrior admission for sepsis with a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey. |
| Sepsis without acute kidney injury (AKI) | – | Other: Pediatric Quality of Life (Peds QL) SurveyPrior admission for sepsis without a diagnosis of AKI as a child. Intervention: The subjects will be administered the Peds QL survey. |
Who may qualify
- Ages
- 2 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects are former patients admitted for sepsis as a child.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Quality of Life (Peds QL) SurveyThe subjects will be administered the Peds QL survey. Children will also have a parental section for parental response. This is NOT an interventional study. | Other | Sepsis with acute kidney injury (AKI), Sepsis without acute kidney injury (AKI) |
Primary outcome
Overall health related quality of life score (HRQOL)
Time frame: Baseline
Scale 0-100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Carmelle Elie, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall health related quality of life score (HRQOL) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.