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CompletedNCT03538769Updated Apr 4, 2019

AKI Management Using Electronic Alerts

An interventional study of electronic alert and clinical decision support system in Acute Kidney Injury, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
6 Months to 18 Years
Sex
All
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Study summary

Acute kidney injury (AKI) is a common clinical event with severe consequences. In the United States alone, greater than one million hospitalized patients per year are diagnosed with AKI. It has been independently associated with prolonged hospital stays, 25-80% risk of in-hospital death, and future progression to chronic kidney disease. While there has been an increase in awareness about the prevalence and significance of AKI, studies have uncovered systematic failure in the management of AKI, largely relating to the failure of clinicians to recognize and manage the condition appropriately. This is where we can use electronic health records (EHRs) and electronic alerts (e-alerts) to our advantage. In this study, the investigators plan to use e-alerts integrated into a clinical decision support (CDS) system to improve the care of and outcomes of patients with AKI. The aims are to study the prevalence of AKI and its progression among hospitalized patients using an 'AKI sniffer' (an EHR based automated system) and to prospectively study if introducing a complex intervention (an e-alert combined with a clinical decision support system) will reduce progression of AKI in children. The investigators have developed an AKI care bundle which provides simple guidelines for management of AKI along with specific discharge instructions to improve follow up care. The primary outcome is AKI progression. Secondary outcomes include morbidity, mortality, length of hospital stay, need for renal replacement therapy, and recovery of renal function by time of hospital discharge. The investigators will also look at documentation of AKI and if these participants get appropriate follow up.

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Conditions studied

  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 240 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

All patients between 6 months-18 years admitted to the surgical and medical floors of Seattle Children's Hospital

Exclusion criteria

Exclusion Criteria:

  1. History of chronic kidney disease stage 4 or worse (i.e., patients on chronic renal replacement therapy or glomerular filtration rate \< 30 mL/min/1.73 m2)
  2. History of renal transplantation within the last 3 months
  3. History of nephrectomy within last 3 months
  4. Patients admitted to observation units
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • No intervention
    Baseline group

    This will be the pre and post alert phase where e-alerts will not be sent to providers

  • Other
    Alert group

    This will be the phase when e-alerts will be sent to the provider

    Other: electronic alert and clinical decision support system

Interventions

  • Otherelectronic alert and clinical decision support system

    Providers taking care of patients will receive an electronic alert and will be guided to use a clinical decision support system

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What researchers measure

Primary outcomes

  1. AKI documentation

    Documentation of AKI in progress notes and discharge summary

    Time frame: 28 days

Secondary outcomes

  1. AKI progression

    Progression of AKI from Stage 1 to Stage 2/3

    Time frame: 7 days

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Study locations

1 site
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
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References and documents

Publications

  • Menon S, Tarrago R, Carlin K, Wu H, Yonekawa K. Impact of integrated clinical decision support systems in the management of pediatric acute kidney injury: a pilot study. Pediatr Res. 2021 Apr;89(5):1164-1170. doi: 10.1038/s41390-020-1046-8. Epub 2020 Jul 3. PubMed 32620006 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03538769
Lead sponsor
Seattle Children's Hospital
Responsible party
Shina Menon (Assistant Professor, Seattle Children's Hospital) — Principal investigator
First posted
May 29, 2018
Start date
Dec 18, 2017
Primary completion
Oct 16, 2018
Completion
Oct 16, 2018
Last update
Apr 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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