NCT03538769

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

May 15, 2018

Last Update Submit

April 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • AKI documentation

    Documentation of AKI in progress notes and discharge summary

    28 days

Secondary Outcomes (1)

  • AKI progression

    7 days

Study Arms (2)

Baseline group

NO INTERVENTION

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

Alert group

OTHER

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

Other: electronic alert and clinical decision support system

Interventions

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

Alert group

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • History of renal transplantation within the last 3 months
  • History of nephrectomy within last 3 months
  • Patients admitted to observation units

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 29, 2018

Study Start

December 18, 2017

Primary Completion

October 16, 2018

Study Completion

October 16, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations