1380 Participants Needed

NGAL Monitoring for Pediatric Acute Kidney Injury

(Taking Focus 2 Trial)

KA
Overseen ByKelli A Krallman, RN, BSN, MS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12367

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.138910

Who Is on the Research Team?

SL

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.
See 2 more

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?
3Treatment groups
Experimental Treatment
Group I: PICU PatientsExperimental Treatment1 Intervention
Group II: NICU PatientsExperimental Treatment1 Intervention
Group III: CICU PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Citations

External validation of the modified sepsis renal angina index for prediction of severe acute kidney injury in children with septic shock. [2023]
Derivation and validation of the renal angina index to improve the prediction of acute kidney injury in critically ill children. [2022]
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]
Assessment of a renal angina index for prediction of severe acute kidney injury in critically ill children: a multicentre, multinational, prospective observational study. [2022]
Use of height-independent baseline creatinine imputation method with renal angina index. [2023]
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]
Assessment of a modified renal angina index for AKI prediction in critically ill adults. [2022]
Diagnostic accuracy of renal angina index alone or in combination with biomarkers for predicting acute kidney injury in children. [2022]
Neutrophil gelatinase-associated lipocalin as a follow-up marker in critically ill pediatric patients with established acute kidney injury. [2016]
Neutrophil-gelatinase-associated lipocalin and renal function after percutaneous coronary interventions. [2022]
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