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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Outcomes; Early Diagnosis
• Intervention / Treatment: Other: Usual care; Device: AKI alert

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4536
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huijuan Mao, PhD,MD; Phone Number: 8613851746819 86-13851746819; Email: huijuanmao@126.com
• Study Contact Backup: Name: Huijuan Mao, PhD,MD; Phone Number: 8613851746819 8613851746819; Email: huijuanmao@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual care; Patients will receive standard clinical care by the doctor in charge.	Other: Usual care; Patients will receive standard clinical care by the doctor in charge.
Experimental: AKI alert; An AKI alert will send to the the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated glomerular filtration rate changed within 7 days	Medical record	within 7 days diagnosed with AKI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seven-day mortality	Medical record	within 7 days diagnosed with AKI
30-day mortality	Medical record	within 30 days diagnosed with AKI
1-year mortality	telephone follow-up	within 1 year diagnosed with AKI
receiving renal replacement therapy at seventh day	Medical record	7 days
receiving renal replacement therapy at 30th day	telephone follow-up	30 days
receiving renal replacement therapy at 1 year	telephone follow-up	1 year
the rate of stage 2 AKI	Medical record	within 7 days diagnosed with AKI
the rate of stage 3 AKI	Medical record	within 7 days diagnosed with AKI
the rate of AKI recovery at 90 day	telephone follow-up	90 days
the rate of timely-recognition of AKI	Medical record	3 days
the interventions for AKI	Medical record	within 7 days diagnosed with AKI
Follow-up rate after discharge	telephone follow-up	1 year

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Huijuan Mao, PhD,MD, Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 2018-SR-180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No