Acute Kidney InjuryPAR4NCT02660931
Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
A study testing AKI Risk Notification in people with Acute Kidney Injury and Renal Injury, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This proposal will incorporate statistical models developed by the investigators to predict risk for acute kidney injury into our electronic medical record system, enabling an alert to notify providers of the risk status. Read more about this study
- Who is it for?
- Ages 28 days to 21 years
- Conditions the study is for
- Acute Kidney Injury, Renal Injury, Kidney Disease
- What is being tested?
- AKI Risk Notification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,108 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2018
- Phase
- Interventional
- 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 28 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All admissions to the pediatric intensive care unit or pediatric wards at the Monroe Carell Junior Children's Hospital at Vanderbilt
Who cannot join
- Prior diagnosis of chronic renal disease, including dialysis and transplant
- Admission to the Neonatal Intensive Care Unit during the current admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
This proposal will incorporate statistical models developed by the investigators to predict risk for acute kidney injury into our electronic medical record system, enabling an alert to notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, who will receive usual care (no notification). The investigators believe the notification will increase appropriate screening for acute kidney injury and reduce the severity of acute kidney injury in the intervention group.
Read the detailed description
This proposal will incorporate a logistic regression models developed by the investigators to predict risk for acute kidney injury in pediatric intensive care unit and pediatric ward patients into the electronic medical record system, enabling personalized decision support. Real-time surveillance using the risk prediction models will identify pediatric inpatients at increased risk for acute kidney injury. When patients exceed the threshold risk for acute kidney injury, the electronic medical record system will notify providers. Patients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, for whom the notification will not display. The risk notification will be assessed for its impact on outcomes including rates of screening for acute kidney injury and the severity of acute kidney injury.
- Conditions
- Acute Kidney Injury, Renal Injury, Kidney Disease
- Being tested
- AKI Risk Notification
- Keywords
- Pediatrics
- Medical subject headings
- Acute Kidney Injury, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI Risk NotificationOther
When a patient's calculated acute kidney injury risk exceeds the threshold value, the electronic medical record will notify the provider of the risk and that appropriate screening (BMP including serum creatinine) may be indicated.
| Study group | Role | What they receive |
|---|---|---|
| AKI Risk Notification | Experimental | Patients randomized to this arm will be eligible for an acute kidney injury risk notification, if their calculated risk exceeds the threshold during their inpatient encounter. Receives: Other: AKI Risk Notification |
| Usual Care | No intervention | These patients will receive usual clinical care, with no acute kidney injury risk notification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serum Creatinine Tests Ordered
Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.
Measured: Admission through Discharge (approximately 2 days to 1 week)
Secondary outcomes (4)
Length of Stay (days)
Number of days in hospital for admission.
Measured: Admission through Discharge (approximately 2 days to 1 week)
Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3)
Worst stage of AKI during hospital stay.
Measured: Admission through Discharge (approximately 2 days to 1 week)
In-hospital Mortality
If any in cohort.
Measured: Admission through Discharge (approximately 2 days to 1 week)
Renal Replacement Therapy (number requiring RRT)
Determined by ICD10 and CPT codes during admission.
Measured: Admission through Discharge (approximately 2 days to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2018
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 Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Van Driest, Vanderbilt University Medical Center
- Investigators
- Sara L Van Driest, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660931
- Sponsor's protocol ID
- 130558
- Acronym
- PAR4
- Status last verified
- Apr 2019
- First submitted
- 18 Jan 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
- ClinicalTrials.gov ID
- NCT02660931
- Acronym / sponsor ID
- PAR4 / 130558
- Conditions
- Acute Kidney Injury, Renal Injury, Kidney Disease
- Keywords
- Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,108 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 21 Jan 2016 (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.
This proposal will incorporate statistical models developed by the investigators to predict risk for acute kidney injury into our electronic medical record system, enabling an alert to notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, who will receive usual care (no notification). The investigators believe the notification will increase appropriate screening for acute kidney injury and reduce the severity of acute kidney injury in the intervention group.
Detailed description
This proposal will incorporate a logistic regression models developed by the investigators to predict risk for acute kidney injury in pediatric intensive care unit and pediatric ward patients into the electronic medical record system, enabling personalized decision support. Real-time surveillance using the risk prediction models will identify pediatric inpatients at increased risk for acute kidney injury. When patients exceed the threshold risk for acute kidney injury, the electronic medical record system will notify providers. Patients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, for whom the notification will not display. The risk notification will be assessed for its impact on outcomes including rates of screening for acute kidney injury and the severity of acute kidney injury.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Risk Notification | Experimental | Other: AKI Risk NotificationPatients randomized to this arm will be eligible for an acute kidney injury risk notification, if their calculated risk exceeds the threshold during their inpatient encounter. |
| Usual Care | No intervention | –These patients will receive usual clinical care, with no acute kidney injury risk notification. |
Who may qualify
- Ages
- 28 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All admissions to the pediatric intensive care unit or pediatric wards at the Monroe Carell Junior Children's Hospital at Vanderbilt
Key exclusion criteria (2 listed)
- Prior diagnosis of chronic renal disease, including dialysis and transplant
- Admission to the Neonatal Intensive Care Unit during the current admission
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 |
|---|---|---|
| AKI Risk NotificationWhen a patient's calculated acute kidney injury risk exceeds the threshold value, the electronic medical record will notify the provider of the risk and that appropriate screening (BMP including serum creatinine) may be indicated. | Other | AKI Risk Notification |
Primary outcome
Number of Serum Creatinine Tests Ordered
Time frame: Admission through Discharge (approximately 2 days to 1 week)
Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.
4 secondary outcomes
Length of Stay (days)
Time frame: Admission through Discharge (approximately 2 days to 1 week)
Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3)
Time frame: Admission through Discharge (approximately 2 days to 1 week)
In-hospital Mortality
Time frame: Admission through Discharge (approximately 2 days to 1 week)
Renal Replacement Therapy (number requiring RRT)
Time frame: Admission through Discharge (approximately 2 days to 1 week)
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 3 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Sara L Van Driest, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI Risk Notification in people with Acute Kidney Injury and Renal Injury, run by Vanderbilt University Medical Center 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 1 inclusion and 2 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 3 Apr 2019. 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?
Number of Serum Creatinine Tests Ordered (time frame: Admission through Discharge (approximately 2 days to 1 week)). 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 3 Apr 2019.