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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02793167
Other study ID # GGH2016-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date June 2022

Study information

Verified date February 2023
Source Guangdong Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. Usual care : patients will receive standard clinical care by the primary physicians 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date June 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AKI alert


Locations

Country Name City State
China Nephrology Dept,Guangdong General Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
XinLing Liang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events during hospitalization cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death from start of AKI to discharge,up to 4 weeks
Primary 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 One year after discharge
Primary The AKI outcome and its occurrence time followed up for 1 years AKI recovery/stop renal replacement therapy One year after discharge
Primary AKI recovery/stop renal replacement therapy Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation from start of AKI to discharge,up to 4 weeks
Secondary Proportion of nephrology referral from start of AKI to discharge,up to 4 weeks
Secondary Diagnostic rate of AKI at discharge from start of AKI to discharge,up to 4 weeks
Secondary Follow-up rate after discharge One year after discharge
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