Back to resultsClinical Values of Automated Electronic Alert for Acute Kidney Injury
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AKI alert
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring acute kidney injury, medication alert systems
Eligibility Criteria
Inclusion Criteria:
- adult patients with an Alert for AKI(based on KDIGO guidelines)
Exclusion Criteria:
- patients already on dialysis for AKI at the time of alert
- patients with End stage renal disease
- patients <18 years of age
- patients dissenting from participation according to the Ethics application
Sites / Locations
- Nephrology Dept,Guangdong General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
AKI alert
Arm Description
patients will receive standard clinical care by the doctor in charge.
an AKI alert will send to the the doctor in charge.Our team of nephrologists would give suggestions if the doctor in charge issue consultation application.
Outcomes
Primary Outcome Measures
Adverse events during hospitalization
cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death
Incidence of cardiovascular disease and its occurrence time followed up for 1 years
heart failure/ acute coronary syndrome/ readmission/cardiac readmission/ cardiovascular intervention or surgery
The AKI outcome and its occurrence time followed up for 1 years
AKI recovery/stop renal replacement therapy
AKI recovery/stop renal replacement therapy
Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation
Secondary Outcome Measures
Proportion of nephrology referral
Diagnostic rate of AKI at discharge
Follow-up rate after discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02793167
Brief Title
Clinical Values of Automated Electronic Alert for Acute Kidney Injury
Official Title
Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
June 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
XinLing Liang
4. Oversight
5. Study Description
Brief Summary
Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.
Detailed Description
A prospective, randomly controlled cohort study will be conducted agmong the patients with AKI who are detected by the use of AKI sniffer. The investigators chose to assess all inpatient serum creatinine results using a combination of "KDIGO" criteria.
The investigators randomly divided the patients into two groups:
Usual care : patients will receive standard clinical care by the primary physicians
AKI alert : an AKI alert will be sent to the the doctor in charge. Our team of kidney experts would give a suggestion if the the doctor in charge issue consultation applications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
acute kidney injury, medication alert systems
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
patients will receive standard clinical care by the doctor in charge.
Arm Title
AKI alert
Arm Type
Experimental
Arm Description
an AKI alert will send to the the doctor in charge.Our team of nephrologists would give suggestions if the doctor in charge issue consultation application.
Intervention Type
Device
Intervention Name(s)
AKI alert
Primary Outcome Measure Information:
Title
Adverse events during hospitalization
Description
cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death
Time Frame
from start of AKI to discharge,up to 4 weeks
Title
Incidence of cardiovascular disease and its occurrence time followed up for 1 years
Description
heart failure/ acute coronary syndrome/ readmission/cardiac readmission/ cardiovascular intervention or surgery
Time Frame
One year after discharge
Title
The AKI outcome and its occurrence time followed up for 1 years
Description
AKI recovery/stop renal replacement therapy
Time Frame
One year after discharge
Title
AKI recovery/stop renal replacement therapy
Description
Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation
Time Frame
from start of AKI to discharge,up to 4 weeks
Secondary Outcome Measure Information:
Title
Proportion of nephrology referral
Time Frame
from start of AKI to discharge,up to 4 weeks
Title
Diagnostic rate of AKI at discharge
Time Frame
from start of AKI to discharge,up to 4 weeks
Title
Follow-up rate after discharge
Time Frame
One year after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients with an Alert for AKI(based on KDIGO guidelines)
Exclusion Criteria:
patients already on dialysis for AKI at the time of alert
patients with End stage renal disease
patients <18 years of age
patients dissenting from participation according to the Ethics application
Facility Information:
Facility Name
Nephrology Dept,Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Values of Automated Electronic Alert for Acute Kidney Injury
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