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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03736304
Collaborator
(none)
3,000
1
2
29
103.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AKI alert
  • Other: Usual care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients: a Single Center Randomized Controlled Trial.
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Estimated glomerular filtration rate changed within 7 days [within 7 days diagnosed with AKI]

    Medical record

Secondary Outcome Measures

  1. seven-day mortality [within 7 days diagnosed with AKI]

    Medical record

  2. 30-day mortality [within 30 days diagnosed with AKI]

    Medical record

  3. 1-year mortality [within 1 year diagnosed with AKI]

    telephone follow-up

  4. receiving renal replacement therapy at seventh day [7 days]

    Medical record

  5. receiving renal replacement therapy at 30th day [30 days]

    telephone follow-up

  6. receiving renal replacement therapy at 1 year [1 year]

    telephone follow-up

  7. the rate of stage 2 AKI [within 7 days diagnosed with AKI]

    Medical record

  8. the rate of stage 3 AKI [within 7 days diagnosed with AKI]

    Medical record

  9. the rate of AKI recovery at 90 day [90 days]

    telephone follow-up

  10. the rate of timely-recognition of AKI [3 days]

    Medical record

  11. the interventions for AKI [within 7 days diagnosed with AKI]

    Medical record

  12. Follow-up rate after discharge [1 year]

    telephone follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Province Hospital Nanjing Jiangsu China 210029

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT03736304
Other Study ID Numbers:
  • 2018-SR-180
First Posted:
Nov 9, 2018
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021