<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/NCT03236831</url>
  </required_header>
  <id_info>
    <org_study_id>17-001893</org_study_id>
    <nct_id>NCT03236831</nct_id>
  </id_info>
  <brief_title>AKI Prevention and Early Intervention in Patients Undergoing VAD Placement</brief_title>
  <official_title>AKI Prevention and Early Intervention in Patients Undergoing VAD Placement</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 find out if more careful assessment and&#xD;
      elimination of potential risk factors of acute kidney injury (AKI) during the subject's&#xD;
      perioperative period will reduce their chance of kidney damage and kidney damage related&#xD;
      problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to investigate whether preventive measures for patients&#xD;
      undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression&#xD;
      and associated complications.&#xD;
&#xD;
      Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5&#xD;
      days after the surgery). The investigators will review the participant's medical record up to&#xD;
      one year after surgery.&#xD;
&#xD;
      The study investigators will access the participant's electronic medical record 24 hours&#xD;
      prior to the planned VAD implantation and review the participant's medication regimen and&#xD;
      provide recommendations to the participant's primary care physician in an effort to minimize&#xD;
      potential risks for AKI. There will be no intervention during the operation.&#xD;
&#xD;
      The clinical recommendations will cover the following:&#xD;
&#xD;
        1. Avoidance of potentially nephrotoxic agents.&#xD;
&#xD;
        2. Optimizing volume status (avoidance of volume overload or depletion)&#xD;
&#xD;
        3. Optimizing electrolytes and acid-base status&#xD;
&#xD;
        4. Minimizing IV contrast exposure when appropriate&#xD;
&#xD;
        5. Treating severe anemia&#xD;
&#xD;
        6. Optimization of hemodynamics (Mean arterial BP&gt;65mmHg).&#xD;
&#xD;
      The investigators plan to compare the results of this study with the historical data in the&#xD;
      same patient population in the years of 7/1/2015-6/30/2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">February 17, 2019</completion_date>
  <primary_completion_date type="Actual">February 17, 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 postoperative AKI (within 5 post-op days) based on AKIN criteria</measure>
    <time_frame>5 days after the surgery</time_frame>
    <description>The Acute Kidney Injury Network (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>Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria</measure>
    <time_frame>5 days after the surgery</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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1 year after the surgery</time_frame>
    <description>The length of hospital stay will be determined from the electronic medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital (perioperative) mortality and one-year mortality</measure>
    <time_frame>Approximately 5 days after surgery, one year after enrollment</time_frame>
    <description>The number of subjects who died in hospital (perioperatively) and one year after surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Subjects Undergoing Prospective VAD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergoing VAD placement. 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 investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following:&#xD;
Avoidance of potentially nephrotoxic medications.&#xD;
Optimizing volume status (avoidance of volume overload or depletion)&#xD;
Optimizing electrolytes and acid-base status&#xD;
Minimizing IV contrast exposure when appropriate&#xD;
Treating severe anemia&#xD;
Optimization of hemodynamics (Mean arterial BP&gt;65mmHg)</description>
    <arm_group_label>Subjects Undergoing Prospective VAD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult patients that will undergo VAD placement.&#xD;
&#xD;
          -  Patients able to give consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients on dialysis (hemodialysis or peritoneal dialysis)&#xD;
&#xD;
          -  Non-elective VAD placement (VAD implantation decision made within 24 hours)&#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, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <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 2, 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>Professor of Medicine and Physiology</investigator_title>
  </responsible_party>
  <keyword>Ventricular Assist Device</keyword>
  <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/NCT03236831
org study id: 17-001893
nct id: NCT03236831
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are doing this research to find out if more careful assessment and
      elimination of potential risk factors of acute kidney injury (AKI) during the subject's
      perioperative period will reduce their chance of kidney damage and kidney damage related
      problems.
The purpose of the study is to investigate whether preventive measures for patients
      undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression
      and associated complications.

      Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5
      days after the surgery). The investigators will review the participant's medical record up to
      one year after surgery.

      The study investigators will access the participant's electronic medical record 24 hours
      prior to the planned VAD implantation and review the participant's medication regimen and
      provide recommendations to the participant's primary care physician in an effort to minimize
      potential risks for AKI. There will be no intervention during the operation.

      The clinical recommendations will cover the following:

        1. Avoidance of potentially nephrotoxic agents.

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

        3. Optimizing electrolytes and acid-base status

        4. Minimizing IV contrast exposure when appropriate

        5. Treating severe anemia

        6. Optimization of hemodynamics (Mean arterial BP>65mmHg).

      The investigators plan to compare the results of this study with the historical data in the
      same patient population in the years of 7/1/2015-6/30/2017.
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 postoperative AKI (within 5 post-op days) based on AKIN criteria
time frame: 5 days after the surgery
description: The Acute Kidney Injury Network (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 postoperative AKI (within 5 post-op days) based on AKIN criteria
time frame: 5 days after the surgery
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: 1 year after the surgery
description: The length of hospital stay will be determined from the electronic medical record.
measure: In hospital (perioperative) mortality and one-year mortality
time frame: Approximately 5 days after surgery, one year after enrollment
description: The number of subjects who died in hospital (perioperatively) and one year after surgery
arm group label: Subjects Undergoing Prospective VAD
arm group type: Other
description: Patients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider.
intervention type: Other
intervention name: Clinical Recommendations
description: The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following:
Avoidance of potentially nephrotoxic medications.
Optimizing volume status (avoidance of volume overload or depletion)
Optimizing electrolytes and acid-base status
Minimizing IV contrast exposure when appropriate
Treating severe anemia
Optimization of hemodynamics (Mean arterial BP>65mmHg)
arm group label: Subjects Undergoing Prospective VAD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Qi Qian, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
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: Professor of Medicine and Physiology
sharing ipd: Undecided