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

1380 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.

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 data supports the effectiveness of the treatment Renal Angina Index (RAI) for monitoring pediatric acute kidney injury?

The Renal Angina Index (RAI) is a tool that helps predict severe acute kidney injury (AKI) in critically ill children, showing better performance than traditional methods. It has been validated in multiple studies, demonstrating high accuracy in identifying children at risk of severe AKI, which can lead to better-targeted interventions and improved outcomes. ^{1 2 3 4 5}

Is NGAL monitoring for pediatric acute kidney injury safe?

The research articles focus on the use of the Renal Angina Index (RAI) and its combination with NGAL for predicting acute kidney injury in children, but they do not provide specific safety data for NGAL monitoring itself. The studies primarily assess the effectiveness of these tools in predicting kidney injury rather than their safety. ^{3 5 6 7 8}

How does NGAL monitoring differ from other treatments for pediatric acute kidney injury?

NGAL monitoring is unique because it uses a biomarker called neutrophil gelatinase-associated lipocalin (NGAL) to predict and monitor acute kidney injury (AKI) in children, which can help identify the condition earlier and more accurately compared to traditional methods. This approach is integrated with the Renal Angina Index (RAI) to improve the prediction of severe AKI, making it a novel tool in managing this condition. ^{3 5 6 9 10}

Research Team

Stuart L Goldstein, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

External validation of the modified sepsis renal angina index for prediction of severe acute kidney injury in children with septic shock. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Derivation and validation of the renal angina index to improve the prediction of acute kidney injury in critically ill children. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Renal Angina Index to Predict the Development of Acute Kidney Injury in Children With Sepsis Who Live in Middle-Income Countries. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Assessment of a renal angina index for prediction of severe acute kidney injury in critically ill children: a multicentre, multinational, prospective observational study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Use of height-independent baseline creatinine imputation method with renal angina index. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Integration of the Renal Angina Index and Urine Neutrophil Gelatinase-Associated Lipocalin Improves Severe Acute Kidney Injury Prediction in Critically Ill Children and Young Adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Assessment of a modified renal angina index for AKI prediction in critically ill adults. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of renal angina index alone or in combination with biomarkers for predicting acute kidney injury in children. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Neutrophil gelatinase-associated lipocalin as a follow-up marker in critically ill pediatric patients with established acute kidney injury. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Neutrophil-gelatinase-associated lipocalin and renal function after percutaneous coronary interventions. [2022]