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

Primary Purpose

Acute Kidney Injury, Outcomes, Early Diagnosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AKI alert
Usual care
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiangsu Province HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

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. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.

Outcomes

Primary Outcome Measures

Estimated glomerular filtration rate changed within 7 days
Medical record

Secondary Outcome Measures

seven-day mortality
Medical record
30-day mortality
Medical record
1-year mortality
telephone follow-up
receiving renal replacement therapy at seventh day
Medical record
receiving renal replacement therapy at 30th day
telephone follow-up
receiving renal replacement therapy at 1 year
telephone follow-up
the rate of stage 2 AKI
Medical record
the rate of stage 3 AKI
Medical record
the rate of AKI recovery at 90 day
telephone follow-up
the rate of timely-recognition of AKI
Medical record
the interventions for AKI
Medical record
Follow-up rate after discharge
telephone follow-up

Full Information

First Posted
November 8, 2018
Last Updated
August 17, 2021
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03736304
Brief Title
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients
Official Title
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients: a Single Center Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Outcomes, Early Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Placebo Comparator
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. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.
Intervention Type
Device
Intervention Name(s)
AKI alert
Intervention Description
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
Other
Intervention Name(s)
Usual care
Intervention Description
Patients will receive standard clinical care by the doctor in charge.
Primary Outcome Measure Information:
Title
Estimated glomerular filtration rate changed within 7 days
Description
Medical record
Time Frame
within 7 days diagnosed with AKI
Secondary Outcome Measure Information:
Title
seven-day mortality
Description
Medical record
Time Frame
within 7 days diagnosed with AKI
Title
30-day mortality
Description
Medical record
Time Frame
within 30 days diagnosed with AKI
Title
1-year mortality
Description
telephone follow-up
Time Frame
within 1 year diagnosed with AKI
Title
receiving renal replacement therapy at seventh day
Description
Medical record
Time Frame
7 days
Title
receiving renal replacement therapy at 30th day
Description
telephone follow-up
Time Frame
30 days
Title
receiving renal replacement therapy at 1 year
Description
telephone follow-up
Time Frame
1 year
Title
the rate of stage 2 AKI
Description
Medical record
Time Frame
within 7 days diagnosed with AKI
Title
the rate of stage 3 AKI
Description
Medical record
Time Frame
within 7 days diagnosed with AKI
Title
the rate of AKI recovery at 90 day
Description
telephone follow-up
Time Frame
90 days
Title
the rate of timely-recognition of AKI
Description
Medical record
Time Frame
3 days
Title
the interventions for AKI
Description
Medical record
Time Frame
within 7 days diagnosed with AKI
Title
Follow-up rate after discharge
Description
telephone follow-up
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huijuan Mao, PhD,MD
Phone
86-13851746819
Ext
8613851746819
Email
huijuanmao@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huijuan Mao, PhD,MD
Phone
8613851746819
Ext
8613851746819
Email
huijuanmao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijuan Mao, PhD,MD
Organizational Affiliation
Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buyun Wu, MD
Phone
8615950594895
Ext
8615950594895
Email
wubuyun@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Huijuan Mao, MD, PhD
First Name & Middle Initial & Last Name & Degree
Buyun Wu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30310097
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.
Results Reference
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PubMed Identifier
26466051
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.
Results Reference
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PubMed Identifier
25726515
Citation
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.
Results Reference
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The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients

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