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

NCT ID: NCT03736304

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury Outcomes Early Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors
All study investigators and participants were blinded to patients randomization status.

Study Groups

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Usual care

Patients will receive standard clinical care by the doctor in charge.

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

Patients will receive standard clinical care by the doctor in charge.

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.

Group Type EXPERIMENTAL

AKI alert

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Usual care

Patients will receive standard clinical care by the doctor in charge.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huijuan Mao, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University

Locations

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Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30310097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26466051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25726515 (View on PubMed)

Li T, Wu B, Li L, Bian A, Ni J, Liu K, Qin Z, Peng Y, Shen Y, Lv M, Lu X, Xing C, Mao H. Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351710. doi: 10.1001/jamanetworkopen.2023.51710.

Reference Type DERIVED
PMID: 38241047 (View on PubMed)

Other Identifiers

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2018-SR-180

Identifier Type: -

Identifier Source: org_study_id

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