NGAL Monitoring for Pediatric Acute Kidney Injury
(Taking Focus 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help children in intensive care who might be at risk for serious kidney problems, particularly after sepsis or surgery. The researchers seek to predict which children could develop severe kidney issues using a special assessment method called the Renal Angina Index (RAI). The focus is on children in the NICU with sepsis or post-surgery, in the PICU with sepsis, and in the CICU after heart surgeries. Children in the ICU without serious long-term kidney problems might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future care for children with similar conditions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Renal Angina Index (RAI) is safe for pediatric patients?
Research has shown that the Renal Angina Index (RAI) predicts the risk of sudden kidney problems in critically ill patients, especially children. Studies have found that a positive RAI score upon admission links to a higher chance of developing these kidney issues. This tool identifies at-risk patients without causing harm or side effects.
As an assessment tool, not a medication or treatment, the RAI lacks the usual safety concerns associated with drugs. It involves collecting and analyzing information to aid doctors in decision-making, which is generally safe and non-invasive.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on the Renal Angina Index (RAI), a novel method for monitoring pediatric acute kidney injury (AKI). Unlike traditional approaches that often rely on changes in serum creatinine levels, which can be delayed, the RAI aims to provide an early warning system by combining clinical risk factors and biomarkers like NGAL (neutrophil gelatinase-associated lipocalin). This early detection allows for proactive management, potentially improving outcomes in critically ill children in NICU, PICU, and CICU settings. By tailoring the RAI calibration to specific patient groups, the trial seeks to enhance the precision of AKI risk assessment, offering a more personalized approach to care.
What evidence suggests that the Renal Angina Index is effective for predicting acute kidney injury?
Research has shown that the Renal Angina Index (RAI) effectively predicts sudden kidney problems, particularly in children. Studies have found that RAI identifies patients at risk of developing these issues more accurately than older methods. For example, one study found that a low RAI score successfully ruled out serious kidney problems by the third day, with a success rate of 92–99%. In this trial, participants in the NICU, PICU, and CICU will undergo RAI calibration specific to their unit, focusing on conditions like sepsis and post-surgical recovery. Further research indicates that RAI is particularly effective at predicting kidney issues in children who have undergone heart surgery. Overall, RAI offers a promising way to detect potential kidney problems early, giving doctors a better chance to prevent serious complications.14567
Who Is on the Research Team?
Stuart L Goldstein, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Are You a Good Fit for This Trial?
This trial is for children and newborns in the PICU, CICU, or NICU at participating hospitals who are at risk of developing severe acute kidney injury due to conditions like sepsis. It's not for those with advanced chronic kidney disease, recent kidney transplants, ongoing AKI needing dialysis before ICU admission, or if they're not expected to need intensive care for more than 48 hours.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Risk Stratification and Biomarker Testing
Participants undergo risk stratification using the renal angina index (RAI) and biomarker testing (NGAL) to identify those at risk for acute kidney injury
Follow-up
Participants are monitored for safety and effectiveness after risk stratification and biomarker testing
What Are the Treatments Tested in This Trial?
Interventions
- Renal Angina Index (RAI)
Trial Overview
The study tests a method using the Renal Angina Index (RAI) combined with biomarker testing and functional assessments to predict which patients will develop fluid overload and severe acute kidney injury after being admitted for sepsis or surgery.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.
Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries
Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Citations
Renal angina index for early identification of risk of acute ...
The rate of AKI was 15% and death rate within 30 days was 13%. Having a positive RAI on admission showed a statistically significant association ...
Modification of the Cardiac Renal Angina Index for ...
The cardiac renal angina index demonstrates strong predictive performance for predicting adverse kidney‐related outcomes in children undergoing ...
Re-evaluating Renal Angina Index: An Authentic, Evidence ...
Conclusion: RAI shows benefit in the prediction of AKI among adult and pediatric populations. However, there is a lack of sufficient data, and ...
Derivation and validation of the renal angina index to ...
An RAI under 8 had high negative predictive values (92–99%) for Day-3 AKI. RAI outperformed traditional markers of pediatric severity of illness (Pediatric Risk ...
5.
academicworks.medicine.hofstra.edu
academicworks.medicine.hofstra.edu/cgi/viewcontent.cgi?article=5779&context=publicationsAssessment of a renal angina index for prediction of severe ...
Compared to isolated, context-free changes in SCr, renal angina risk assessment improved accuracy for prediction of severe AKI in critically ill children and ...
The Renal Angina Index to Predict Acute Kidney Injury
A conceptual model, termed “renal angina,” to identify critically ill patients at risk for AKI at the time of intensive care unit (ICU) admission.
7.
journals.lww.com
journals.lww.com/ccmjournal/fulltext/2025/01001/1420__renal_angina_index__rai__as_a_predictor_of.1373.aspx1420: renal angina index (rai) as a predictor of renal injury ...
The Renal Angina Index (RAI) was initially developed for pediatric populations to predict the progression to acute kidney injury (AKI) based on KDIGO criteria.
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