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NGAL Monitoring for Pediatric Acute Kidney Injury (Taking Focus 2 Trial)

N/A

Waitlist Available

Led By Stuart L Goldstein, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission

Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.736m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will help doctors better predict and treat children at risk for developing severe acute kidney injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, traditional side effects are minimal. However, there may be some discomfort or risks associated with collecting blood samples or other necessary tests used in assessing renal function.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My kidney function is very low (stage IV or V CKD).

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I had a kidney transplant in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Decision Support Performance

Secondary study objectives

Rate of Clinical Decision Support Completion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: PICU PatientsExperimental Treatment1 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 PatientsExperimental Treatment1 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 PatientsExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met