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

NCT ID: NCT05114057

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-07-01

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Acute Kidney Injury Due to Sepsis Neonatal Sepsis

Keywords

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Renal Angina Index NGAL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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PICU Patients

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 Type OTHER

Renal Angina Index (RAI)

Intervention Type OTHER

Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

CICU Patients

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

Group Type OTHER

Renal Angina Index (RAI)

Intervention Type OTHER

Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

NICU Patients

Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries

Group Type OTHER

Renal Angina Index (RAI)

Intervention Type OTHER

Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

Interventions

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Renal Angina Index (RAI)

Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart L Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Kelli A Krallman, RN, BSN, MS

Role: CONTACT

Phone: 513-636-4837

Email: [email protected]

Facility Contacts

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Kelli A Krallman, RN, BSN, MS

Role: primary

Stuart L Goldstein, MD

Role: backup

Katja Gist, DO

Role: backup

Cara Slagle, MD

Role: backup

Natalja Stanski, MD

Role: backup

Other Identifiers

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CIN002 - Taking Focus 3

Identifier Type: -

Identifier Source: org_study_id