Clinical trial NCT03736304: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Outcomes
Early Diagnosis
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 4536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Estimated glomerular filtration rate changed within 7 days
timeFrame: within 7 days diagnosed with AKI
Secondary outcomes:
measure: seven-day mortality
timeFrame: within 7 days diagnosed with AKI
measure: 30-day mortality
timeFrame: within 30 days diagnosed with AKI
measure: 1-year mortality
timeFrame: within 1 year diagnosed with AKI
measure: receiving renal replacement therapy at seventh day
timeFrame: 7 days
measure: receiving renal replacement therapy at 30th day
timeFrame: 30 days
measure: receiving renal replacement therapy at 1 year
timeFrame: 1 year
measure: the rate of stage 2 AKI
timeFrame: within 7 days diagnosed with AKI
measure: the rate of stage 3 AKI
timeFrame: within 7 days diagnosed with AKI
measure: the rate of AKI recovery at 90 day
timeFrame: 90 days
measure: the rate of timely-recognition of AKI
timeFrame: 3 days
measure: the interventions for AKI
timeFrame: within 7 days diagnosed with AKI
measure: Follow-up rate after discharge
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University
name: Huijuan Mao, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.