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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

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:
Select...
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).
Select...
I had a kidney transplant in the last 3 months.

Timeline

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

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

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
827 Previous Clinical Trials
6,563,067 Total Patients Enrolled
17 Trials studying Acute Kidney Injury
9,972 Patients Enrolled for Acute Kidney Injury
Stuart L Goldstein, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
3 Previous Clinical Trials
142 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
142 Patients Enrolled for Acute Kidney Injury

Media Library

NICU Patients Clinical Trial Eligibility Overview. Trial Name: NCT05114057 — N/A
Acute Kidney Injury Research Study Groups: NICU Patients, PICU Patients, CICU Patients
Acute Kidney Injury Clinical Trial 2023: NICU Patients Highlights & Side Effects. Trial Name: NCT05114057 — N/A
NICU Patients 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114057 — N/A
~920 spots leftby Aug 2027