Clinical trial NCT03541785: Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric AKI
Official title: Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children With Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Kidney Injury
Renal Replacement Therapy
Pediatric Intensive Care Units
Keywords: NGAL
Renal Angina Index
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-31
Enrollment: 420
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center at risk for developing Acute Kidney Injury

Brief summary: This study follows a group of patients admitted to the PICU 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 patients who will become fluid overloaded and develop acute kidney injury.

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 developed, tested, and integrated an AKI risk-stratification/clinical recognition tool (RAI) and a urine biomarker (NGAL) to try to identify patients at risk vs. not at-risk for developing AKI. However, these factors alone have yet to be integrated into clinical decision support to optimize AKI therapies and patient outcomes. The furosemide stress test (FST), previously described in adults, may be a good predictor for the patients who need acute dialysis for AKI versus those that can be managed medically.

Through this study, the investigators will be following a cohort of patients admitted to the PICU who are identified as being at risk for developing AKI through RAI and NGAL results. The aim is to standardize the FST in this population, as well as determine the accuracy of the RAI-NGAL-FST clinical decision tool in predicting patients who become fluid overloaded and develop AKI.

Eligibility criteria: Inclusion Criteria:

* Admitted to the Pediatric Intensive Care Unit (PICU)
* Renal Angina Index (RAI) greater than or equal to 8
* Urine NGAL greater than or equal to 150 ng/mL
* Indwelling urinary catheter

Exclusion Criteria:

* Evidence of volume depletion
* Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \<60 mL/min/1.73m2)
* History of kidney transplantation
* Active DNR order or clinical team is not committed to escalating medical care
* Known history of allergic reaction to furosemide (only for FST)

Primary outcomes:
measure: Clinical Decision Support Success (CDS)
timeFrame: 48 hours of PICU admission
Secondary outcomes:
measure: Furosemide Stress Test (FST) Standardization
timeFrame: 12 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stuart Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: