Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI (Taking Focus 2)
Primary Purpose
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis, Neonatal Sepsis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renal Angina Index (RAI)
Sponsored by
About this trial
This is an interventional screening trial for Acute Kidney Injury focused on measuring Renal Angina Index, NGAL
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
PICU Patients
CICU Patients
NICU Patients
Arm Description
Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.
Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass
Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries
Outcomes
Primary Outcome Measures
Clinical Decision Support Performance
Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV)
Secondary Outcome Measures
Rate of Clinical Decision Support Completion
Time to complete the risk stratification and biomarker testing is less than 48 hours
Full Information
NCT ID
NCT05114057
First Posted
October 20, 2021
Last Updated
January 25, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT05114057
Brief Title
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
Acronym
Taking Focus 2
Official Title
Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates With Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis, Neonatal Sepsis
Keywords
Renal Angina Index, NGAL
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PICU Patients
Arm Type
Other
Arm Description
Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors.
Arm Title
CICU Patients
Arm Type
Other
Arm Description
Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass
Arm Title
NICU Patients
Arm Type
Other
Arm Description
Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries
Intervention Type
Other
Intervention Name(s)
Renal Angina Index (RAI)
Intervention Description
Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury
Primary Outcome Measure Information:
Title
Clinical Decision Support Performance
Description
Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV)
Time Frame
Days 2-4 after ICU admission
Secondary Outcome Measure Information:
Title
Rate of Clinical Decision Support Completion
Description
Time to complete the risk stratification and biomarker testing is less than 48 hours
Time Frame
48 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelli A Krallman, RN, BSN, MS
Phone
513-636-4837
Email
kelli.krallman@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart L Goldstein, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelli A Krallman, RN, BSN, MS
Email
kelli.krallman@cchmc.org
First Name & Middle Initial & Last Name & Degree
Stuart L Goldstein, MD
First Name & Middle Initial & Last Name & Degree
Katja Gist, DO
First Name & Middle Initial & Last Name & Degree
Cara Slagle, MD
First Name & Middle Initial & Last Name & Degree
Natalja Stanski, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
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