<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/NCT03236103</url>
  </required_header>
  <id_info>
    <org_study_id>17-002670</org_study_id>
    <nct_id>NCT03236103</nct_id>
  </id_info>
  <brief_title>AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.</brief_title>
  <official_title>AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are doing this research to investigate whether multifaceted preventive&#xD;
      measures for newly hospitalized ventricular assist device (VAD) patients will reduce the&#xD;
      Acute Kidney Injury (AKI) occurrence rate, progression and associated complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to investigate whether preventive measures for newly hospitalized&#xD;
      ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence&#xD;
      rate, progression and associated complications&#xD;
&#xD;
      Participants will be in the study for the first 7 days of hospitalization. The study&#xD;
      investigators will access the electronic medical record daily from admission day 1 through&#xD;
      admission day 7 in order to provide clinical recommendations in an effort to minimize AKI&#xD;
      risk as per routine practice.&#xD;
&#xD;
      If the patient is discharged prior to day 7 the study, intervention will be terminated on day&#xD;
      of discharge.&#xD;
&#xD;
      The investigators will review the participant's medical record up to one year after surgery.&#xD;
&#xD;
      This study will not include any experimental laboratory tests or experimental medication.&#xD;
&#xD;
      The clinical recommendations will regard the following:&#xD;
&#xD;
        1. Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast,&#xD;
           nephrotoxic antimicrobials)&#xD;
&#xD;
        2. Optimizing volume status (avoidance of volume overload or depletion)&#xD;
&#xD;
        3. Optimizing electrolytes and acid-base status&#xD;
&#xD;
        4. Optimizing hemodynamics (Mean arterial BP&gt;65mmHg)&#xD;
&#xD;
        5. Assessment of kidney function with serum creatinine and/or cystatin C None of the&#xD;
           suggestions will be experimental. All suggestions will be based on standard nephrology&#xD;
           practice.&#xD;
&#xD;
      The investigators plan to compare the results of the current study with those in in the years&#xD;
      of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">April 8, 2019</completion_date>
  <primary_completion_date type="Actual">April 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label single group interventional study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of AKI in hospitalized VAD patients based on AKIN criteria</measure>
    <time_frame>The first 7 days of hospitalization</time_frame>
    <description>The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output &lt;0.5 ml/kg/h for 6 h; 2) serum creatinine increase &gt; 2.0-3.0 fold from baseline OR urine output &lt;0.5 ml/kg/h for 12 h; 3) serum creatinine increase &gt;3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output &lt;0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of AKI based on AKIN stages (I, II, III) 1</measure>
    <time_frame>The first 7 days of the hospitalization</time_frame>
    <description>The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output &lt;0.5 ml/kg/h for 6 h; 2) serum creatinine increase &gt; 2.0-3.0 fold from baseline OR urine output &lt;0.5 ml/kg/h for 12 h; 3) serum creatinine increase &gt;3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output &lt;0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>One year after hospitalization</time_frame>
    <description>The length of hospital stay will be determined from the electronic medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital, 60 day and one-year mortality</measure>
    <time_frame>One year after enrollment</time_frame>
    <description>The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">900</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Subjects with VAD in place</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Adult patients with VAD in place who are admitted to the hospital for acute medical illness. The investigators will provide clinical recommendations to the subject's primary care provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Recommendations</intervention_name>
    <description>The clinical recommendations will regard the following:&#xD;
Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)&#xD;
Optimizing volume status (avoidance of volume overload or depletion)&#xD;
Optimizing electrolytes and acid-base status&#xD;
Optimizing hemodynamics (Mean arterial BP&gt;65mmHg)&#xD;
Assessment of kidney function with serum creatinine and/or cystatin C&#xD;
None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.</description>
    <arm_group_label>Subjects with VAD in place</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Adult patients with VAD in place who are admitted to the hospital for acute medical illness&#xD;
        during the study period. For those with multiple admissions during the study period only&#xD;
        the first admission will be studied.&#xD;
&#xD;
        Patients who are able to give consent. In case of patients that are mentally impaired we&#xD;
        will obtain consent from power of attorney and when patients regain intact mental capacity&#xD;
        we will reobtain consent from the patient.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients on dialysis (hemodialysis or peritoneal dialysis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qi Qian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Qi Qian, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ventricular assist device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03236103
org study id: 17-002670
nct id: NCT03236103
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are doing this research to investigate whether multifaceted preventive
      measures for newly hospitalized ventricular assist device (VAD) patients will reduce the
      Acute Kidney Injury (AKI) occurrence rate, progression and associated complications
The purpose of the study is to investigate whether preventive measures for newly hospitalized
      ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence
      rate, progression and associated complications

      Participants will be in the study for the first 7 days of hospitalization. The study
      investigators will access the electronic medical record daily from admission day 1 through
      admission day 7 in order to provide clinical recommendations in an effort to minimize AKI
      risk as per routine practice.

      If the patient is discharged prior to day 7 the study, intervention will be terminated on day
      of discharge.

      The investigators will review the participant's medical record up to one year after surgery.

      This study will not include any experimental laboratory tests or experimental medication.

      The clinical recommendations will regard the following:

        1. Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast,
           nephrotoxic antimicrobials)

        2. Optimizing volume status (avoidance of volume overload or depletion)

        3. Optimizing electrolytes and acid-base status

        4. Optimizing hemodynamics (Mean arterial BP>65mmHg)

        5. Assessment of kidney function with serum creatinine and/or cystatin C None of the
           suggestions will be experimental. All suggestions will be based on standard nephrology
           practice.

      The investigators plan to compare the results of the current study with those in in the years
      of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label single group interventional study
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of AKI in hospitalized VAD patients based on AKIN criteria
time frame: The first 7 days of hospitalization
description: The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
measure: Severity of AKI based on AKIN stages (I, II, III) 1
time frame: The first 7 days of the hospitalization
description: The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
measure: Length of hospital stay
time frame: One year after hospitalization
description: The length of hospital stay will be determined from the electronic medical record.
measure: In hospital, 60 day and one-year mortality
time frame: One year after enrollment
description: The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization
arm group label: Subjects with VAD in place
arm group type: Other
description: Adult patients with VAD in place who are admitted to the hospital for acute medical illness. The investigators will provide clinical recommendations to the subject's primary care provider.
intervention type: Other
intervention name: Clinical Recommendations
description: The clinical recommendations will regard the following:
Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)
Optimizing volume status (avoidance of volume overload or depletion)
Optimizing electrolytes and acid-base status
Optimizing hemodynamics (Mean arterial BP>65mmHg)
Assessment of kidney function with serum creatinine and/or cystatin C
None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.
arm group label: Subjects with VAD in place
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Qi Qian
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Qi Qian, M.D.
investigator title: Principal Investigator
mesh term: Acute Kidney Injury
sharing ipd: Undecided