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

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ClinicalTrials.gov Identifier: NCT03736304
Recruitment Status : Not yet recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

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, we 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
Acute Kidney Injury Outcomes Early Diagnosis Device: AKI alert Other: Usual care Not Applicable

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, we 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. Our team of kidney experts would give a suggestion if the doctor in charge need a renal consultation.


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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

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




Primary Outcome Measures :
  1. Estimated glomerular filtration rate changed within 7 days [ Time Frame: within 7 days diagnosed with AKI ]
    Medical record


Secondary Outcome Measures :
  1. seven-day mortality [ Time Frame: within 7 days diagnosed with AKI ]
    Medical record

  2. 30-day mortality [ Time Frame: within 30 days diagnosed with AKI ]
    Medical record

  3. 1-year mortality [ Time Frame: within 1 year diagnosed with AKI ]
    telephone follow-up

  4. receiving renal replacement therapy at seventh day [ Time Frame: 7 days ]
    Medical record

  5. receiving renal replacement therapy at 30th day [ Time Frame: 30 days ]
    telephone follow-up

  6. receiving renal replacement therapy at 1 year [ Time Frame: 1 year ]
    telephone follow-up

  7. the rate of stage 2 AKI [ Time Frame: within 7 days diagnosed with AKI ]
    Medical record

  8. the rate of stage 3 AKI [ Time Frame: within 7 days diagnosed with AKI ]
    Medical record

  9. the rate of AKI recovery at 90 day [ Time Frame: 90 days ]
    telephone follow-up

  10. the rate of timely-recognition of AKI [ Time Frame: 3 days ]
    Medical record

  11. the interventions for AKI [ Time Frame: within 7 days diagnosed with AKI ]
    Medical record

  12. Follow-up rate after discharge [ Time Frame: 1 year ]
    telephone follow-up



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736304


Contacts
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Contact: Huijuan Mao, PhD,MD 86-13851746819 ext 8613851746819 huijuanmao@126.com
Contact: Huijuan Mao, PhD,MD 8613851746819 ext 8613851746819 huijuanmao@126.com

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Huijuan Mao, PhD,MD Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University

Publications:
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03736304     History of Changes
Other Study ID Numbers: 2018-SR-180
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases