<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464031</url>
  </required_header>
  <id_info>
    <org_study_id>20181015</org_study_id>
    <nct_id>NCT04464031</nct_id>
  </id_info>
  <brief_title>Electronic Alert for Acute Kidney Injury in Geriatric Wards</brief_title>
  <official_title>Study on the Application Value of Electronic Alert for Acute Kidney Injury in Geriatric Wards</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Operating acute kidney injury electronic alert in geriatric wards; Acute authenticity&#xD;
      evaluation of acute kidney injury electronic alert; To explore the clinical value of&#xD;
      electronic alert for acute kidney injury prevention and treatment in geriatric wards.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis rate of acute kidney injury (Rate of missed diagnosis);</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of dialysis</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of death</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of nephrology consultation</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of nephrology follow-up</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function after 90 days of acute kidney injury</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Alert group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electronic alert</intervention_name>
    <description>The e-alert system was developed by the divisions of Nephrology and Information Management of Guangdong Provincial People's Hospital (Patent Application 201610001950.5). The alert system made a diagnosis of acute kidney injury according to Kidney Disease: Improving Global Outcomes criteria. Then, the doctor receives an alert of acute kidney injury.</description>
    <arm_group_label>Alert group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 65 years old&#xD;
&#xD;
          -  Diagnose of acute kidney injury by e-alert&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Baseline serum creatinine &gt; 4mg/dL&#xD;
&#xD;
          -  Stage-5 chronic kidney disease or maintenance hemodialysis&#xD;
&#xD;
          -  Kidney transplantation&#xD;
&#xD;
          -  Amputation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute kidney injury</keyword>
  <keyword>Alert</keyword>
  <keyword>Geriatric wards</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464031
org study id: 20181015
nct id: NCT04464031
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Operating acute kidney injury electronic alert in geriatric wards; Acute authenticity
      evaluation of acute kidney injury electronic alert; To explore the clinical value of
      electronic alert for acute kidney injury prevention and treatment in geriatric wards.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnosis rate of acute kidney injury (Rate of missed diagnosis);
time frame: 1 year
measure: Rate of dialysis
time frame: 1 year
measure: Rate of death
time frame: 1 year
measure: Rate of nephrology consultation
time frame: 1 year
measure: Rate of nephrology follow-up
time frame: 1 year
measure: Renal function after 90 days of acute kidney injury
time frame: 1 year
arm group label: Alert group
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Other
intervention name: electronic alert
description: The e-alert system was developed by the divisions of Nephrology and Information Management of Guangdong Provincial People's Hospital (Patent Application 201610001950.5). The alert system made a diagnosis of acute kidney injury according to Kidney Disease: Improving Global Outcomes criteria. Then, the doctor receives an alert of acute kidney injury.
arm group label: Alert group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No