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

NCT03736304 | Completed

• 1 other identifier: 2018-SR-180
• Study Type: interventional
• Target: 4,536
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Outcomes; Early Diagnosis

Outcome Measures

Primary Outcomes (1)

• Estimated glomerular filtration rate changed within 7 days

  Medical record

  within 7 days diagnosed with AKI

Secondary Outcomes (12)

• seven-day mortality

  within 7 days diagnosed with AKI

• 30-day mortality

  within 30 days diagnosed with AKI

• 1-year mortality

  within 1 year diagnosed with AKI

• receiving renal replacement therapy at seventh day

  7 days

• receiving renal replacement therapy at 30th day

  30 days

Study Arms (2)

Usual care

PLACEBO COMPARATOR

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

Other: Usual care

AKI alert

EXPERIMENTAL

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

Interventions

AKI alert 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.

AKI alert

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Related Publications (4)

• 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.

  PMID: 30310097 BACKGROUND

• 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.

  PMID: 26466051 BACKGROUND

• 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.

  PMID: 25726515 BACKGROUND

• 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.

  PMID: 38241047 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huijuan Mao, PhD,MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All study investigators and participants were blinded to patients randomization status.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: August 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

CN (1)