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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03538769
Other study ID # STUDY00000811
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2017
Est. completion date October 16, 2018

Study information

Verified date April 2019
Source Seattle Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date October 16, 2018
Est. primary completion date October 16, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria:

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

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
electronic 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

Locations

Country Name City State
United States Seattle Children's Hospital Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AKI documentation Documentation of AKI in progress notes and discharge summary 28 days
Secondary AKI progression Progression of AKI from Stage 1 to Stage 2/3 7 days
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