FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

The goal of this study is to learn whether adding a clinical decision support tool to the electronic medical record helps clinicians use the furosemide stress test in critically ill children at high risk for severe acute kidney injury (AKI). The main question it aims to answer is: Does implementing the decision support tool reduce fluid overload and help predict which children will receive dialysis?

Researchers will identify children admitted to the pediatric intensive care unit who are at high risk for AKI using risk stratification and biomarker testing, then compare outcomes in the two years after the tool is introduced with the two years before.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to the pediatric intensive care unit (PICU)

Renal Angina Index (RAI) greater than or equal to 8 (RAI+)

Urine NGAL greater than or equal to 150 ng/mL (NGAL+)

Disqualifiers

Receipt of renal replacement therapy prior to PICU admission

Trial population

Critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center identified as being high risk for developing AKI (RAI+/NGAL+)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Furosemide Stress Test Clinical Decision Support Tool

    Other intervention

    The CDS strategy will be developed with key stakeholders in the Cincinnati Children's PICU, leveraging existing infrastructure and workflows. This CDS intervention will then be implemented as part of routine care in the PICU.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Post-Implementation Cohort1 intervention

Trial outcomes

Primary outcomes

1

Change in Day 7 Fluid Accumulation

Median Day 7 percent fluid accumulation will be compared between eligible patients in the 2 years post-implementation and the 2 years pre-implementation. Percent fluid accumulation will be calculated as cumulative fluid balance (in liters) divided by baseline body weight (in kilograms) multiplied by 100 to obtain a percentage.

Time frame
2 years

Secondary outcomes

1

Implementation Acceptability, Feasibility, and Fidelity

Acceptability to clinicians, feasibility to implement within PICU workflows, and fidelity of delivery of intervention will be assessed. Acceptability and feasibility will be measured with the Acceptability of Intervention Measure (AIM) and Feasibility of Intervention measure (FIM) tools. Results of each tool will be analyzed to determine the mean and standard deviation of each question and summary scores for the complete tool. Fidelity will be assessed by comparing the proportion of RAI+/NGAL+ patients who receive an FST in the post-implementation period compared to the pre-implementation period. Barriers and facilitators to fidelity of our intervention will be explores using semi-structured interviews (SSIs) and RedCap surveys of clinicians.

Time frame
2 years
2

Change in ICU Free Days

Median ICU free days will be compared between eligible patients in the 2 years post-implementation and the 2 years pre-implementation. ICU free days will be calculated as 28 days minus the total number of days in the ICU with patients who die before day 28 assigned 0.

Time frame
2 years
3

Change in Continuous Renal Replacement Therapy Use

Rate of CRRT use, timing of initiation, and duration between eligible patients in the 2 years post-implementation to the 2 years pre-implementation.

Time frame
2 years
4

Change in Vasoactive Inotropic Score after FST

For patients who undergo FST, change in Vasoactive Intropic Score (VIS) will be compared from immediately before FST to 2 hours after FST. This will serve as a balancing measure to evaluate safety of intervention.

Time frame
2 hours

Other outcomes

Sponsors and contacts

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