NCT03541785

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jul 2018Jun 2029

First Submitted

Initial submission to the registry

May 16, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

May 16, 2018

Last Update Submit

March 19, 2026

Conditions

Acute Kidney InjuryRenal Replacement TherapyPediatric Intensive Care Units

Keywords

NGALRenal Angina Index

Outcome Measures

Primary Outcomes (1)

  • Clinical Decision Support Success (CDS)

    Time to complete risk stratification (RAI), biomarker testing (NGAL), and functional kidney assessment (FST) is less than 48 hours

    48 hours of PICU admission

Secondary Outcomes (1)

  • Furosemide Stress Test (FST) Standardization

    12 months

Eligibility Criteria

Age3 Months - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Stuart Goldstein, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 31, 2018

Study Start

July 1, 2018

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(1)