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NCT05114057 | NOT YET RECRUITING | Acute Kidney Injury

Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
Sponsor:

Children's Hospital Medical Center, Cincinnati

Brief Summary:

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.

Condition or disease

Acute Kidney Injury

Acute Kidney Injury Due to Sepsis

Neonatal Sepsis

Intervention/treatment

Renal Angina Index (RAI)

Phase

NA

Detailed Description:

In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1380 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates with Acute Kidney Injury
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2028-08-31
Estimated Study Completion Date : 2029-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 25 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • * Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \<60 mL/min/1.736m2)
  • * History of kidney transplant within the previous 90 days
  • * Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission
  • * Acute DNR order or clinical team is not committed to escalating medical care
  • * Anticipated to require intensive care for less than 48 hours
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI

Location Details

NCT05114057

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229