NGAL Monitoring for Pediatric Acute Kidney Injury

(Taking Focus 2 Trial)

Overseen By Kelli A Krallman, RN, BSN, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Chronic kidney disease, Kidney transplant, Ongoing AKI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{1 4 5 6 7}

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

Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution

Exclusion Criteria

I started kidney replacement therapy before being admitted to the ICU due to acute kidney issues.

You are not expected to need intensive care for more than 48 hours.

You have a "do not resuscitate" order in place, or the medical team is not willing to provide advanced medical care if needed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

2-4 days

In-hospital assessment

Follow-up

Participants are monitored for safety and effectiveness after risk stratification and biomarker testing

4 weeks

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?

Group I: PICU Patients Experimental Treatment 1 Intervention

Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.

Group II: NICU Patients Experimental Treatment 1 Intervention

Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries

Group III: CICU Patients Experimental Treatment 1 Intervention

Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37796325/

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 ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.042941

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 ...

3. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.682672/full

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0085253815562236

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=publications

Assessment 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5976853/

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.aspx

1420: 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.