The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients

Acute Kidney Injury Clinical Trial

Official title:

The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients: a Single Center Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736304
• Other study ID #: 2018-SR-180
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.

Description:

Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.

The patients were randomly divided 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 doctor in charge. The team of kidney experts would give a suggestion if the doctor in charge need a renal consultation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4536
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized adult patients with an Alert for AKI(based on KDIGO guidelines)

Exclusion Criteria:

• Patients already having eGFR<15ml/min/1.73m2 or receiving renal replacement therapy for AKI at the time of alert.

• Patients already having a AKI before admission.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Early Diagnosis
• Outcomes
• Wounds and Injuries

Intervention

Device:
• AKI alert
An AKI alert will send to the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.

Other:
• Usual care
Patients will receive standard clinical care by the doctor in charge.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26. — View Citation

Wu B, Li L, Cheng X, Yan W, Liu Y, Xing C, Mao H. Propensity-score-matched evaluation of under-recognition of acute kidney injury and short-term outcomes. Sci Rep. 2018 Oct 11;8(1):15171. doi: 10.1038/s41598-018-33103-9. — View Citation

Yang L, Xing G, Wang L, Wu Y, Li S, Xu G, He Q, Chen J, Chen M, Liu X, Zhu Z, Yang L, Lian X, Ding F, Li Y, Wang H, Wang J, Wang R, Mei C, Xu J, Li R, Cao J, Zhang L, Wang Y, Xu J, Bao B, Liu B, Chen H, Li S, Zha Y, Luo Q, Chen D, Shen Y, Liao Y, Zhang Z, Wang X, Zhang K, Liu L, Mao P, Guo C, Li J, Wang Z, Bai S, Shi S, Wang Y, Wang J, Liu Z, Wang F, Huang D, Wang S, Ge S, Shen Q, Zhang P, Wu L, Pan M, Zou X, Zhu P, Zhao J, Zhou M, Yang L, Hu W, Wang J, Liu B, Zhang T, Han J, Wen T, Zhao M, Wang H; ISN AKF 0by25 China Consortiums. Acute kidney injury in China: a cross-sectional survey. Lancet. 2015 Oct 10;386(10002):1465-71. doi: 10.1016/S0140-6736(15)00344-X. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated glomerular filtration rate changed within 7 days	Medical record	within 7 days diagnosed with AKI
Secondary	seven-day mortality	Medical record	within 7 days diagnosed with AKI
Secondary	30-day mortality	Medical record	within 30 days diagnosed with AKI
Secondary	1-year mortality	telephone follow-up	within 1 year diagnosed with AKI
Secondary	receiving renal replacement therapy at seventh day	Medical record	7 days
Secondary	receiving renal replacement therapy at 30th day	telephone follow-up	30 days
Secondary	receiving renal replacement therapy at 1 year	telephone follow-up	1 year
Secondary	the rate of stage 2 AKI	Medical record	within 7 days diagnosed with AKI
Secondary	the rate of stage 3 AKI	Medical record	within 7 days diagnosed with AKI
Secondary	the rate of AKI recovery at 90 day	telephone follow-up	90 days
Secondary	the rate of timely-recognition of AKI	Medical record	3 days
Secondary	the interventions for AKI	Medical record	within 7 days diagnosed with AKI
Secondary	Follow-up rate after discharge	telephone follow-up	1 year