<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/NCT03244514</url>
  </required_header>
  <id_info>
    <org_study_id>07-AnIt-16</org_study_id>
    <nct_id>NCT03244514</nct_id>
  </id_info>
  <brief_title>Biomarker-guided Implementation of the AKI Bundle</brief_title>
  <acronym>PrevAKI-mc</acronym>
  <official_title>Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Society of Intensive Care Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Muenster</source>
  <oversight_info>
    <has_dmc>Yes</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>
      There is no specific therapy for acute kidney injury. It is presumed that supportive measures&#xD;
      improve the care and outcome of patients with acute kidney injury.&#xD;
&#xD;
      The investigators hypothesize that the implementation of a bundle of supportive measures&#xD;
      adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.&#xD;
&#xD;
      A Randomized prospective multicenter trial is needed to investigate whether the&#xD;
      implementation of the bundle of measures is effective to prevent AKI in high risk patients&#xD;
      undergoing cardiac surgery. In this feasibility trial the investigators will analyze the&#xD;
      compliance rate to the trial protocol in a multicenter, multinational cohort in preparation&#xD;
      for a large randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2017</start_date>
  <completion_date type="Actual">January 26, 2020</completion_date>
  <primary_completion_date type="Actual">October 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance rate</measure>
    <time_frame>48 hours after start of intervention</time_frame>
    <description>proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence of AKI</measure>
    <time_frame>72 hours after start of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate and severe AKI</measure>
    <time_frame>72 hours after start of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free-days through of vasoactive medications and mechanical ventilation</measure>
    <time_frame>28 days after start of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal recovery</measure>
    <time_frame>90 days after start of intervention</time_frame>
    <description>renal recovery is defined as serum creatinine levels &lt; 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days after start of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU and hospital stay</measure>
    <time_frame>up to 1 year after start of intervention (until discharge)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with renal replacement therapy</measure>
    <time_frame>90 days after start of intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Acute Kidney Injury (Nontraumatic)</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implementation of the cardiovascular surgery AKI bundle&#xD;
discontinuation of all nephrotoxic agents when possible&#xD;
optimization of volume status and hemodynamic parameters&#xD;
close monitoring of serum creatinine, fluid balance and urinary output&#xD;
avoidance of hyperglycemia&#xD;
considerations of alternatives to radiocontrast agents&#xD;
discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period&#xD;
avoidance of HES, gelatin, and chlorid-rich solutions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients will receive standard of care (according to each center)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Implementation of the cardiovascular AKI bundle (see arm description)</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)&#xD;
&#xD;
          -  Urinary [TIMP-2] * [IGFBP7] &gt;= 0.3 4h after CPB&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting AKI (stage 1 and higher)&#xD;
&#xD;
          -  Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)&#xD;
&#xD;
          -  Pregnancy, breastfeeding&#xD;
&#xD;
          -  Known (Glomerulo-)-Nephritis, intersstitial nephritis or vasculitis&#xD;
&#xD;
          -  CKD with eGFR &lt; 20 mL/min&#xD;
&#xD;
          -  Dialyses dependent CKD&#xD;
&#xD;
          -  Prior kidney transplant within the last 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zarbock, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Muenster, Dept. of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Brugmann, Intensive Care Medicine</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bergmannsheil Bochum</name>
      <address>
        <city>Bochum</city>
        <zip>D-44789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie</name>
      <address>
        <city>Gießen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philipps-Universität Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>D-35033</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>D-48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific</name>
      <address>
        <city>Milano</city>
        <zip>I-20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele S.r.I., I.R.C.C.S.</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Meersch M, Schmidt C, Hoffmeier A, Van Aken H, Wempe C, Gerss J, Zarbock A. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1551-1561. doi: 10.1007/s00134-016-4670-3. Epub 2017 Jan 21. Erratum In: Intensive Care Med. 2017 Mar 7;:</citation>
    <PMID>28110412</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>KDIGO-Guideline</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>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/NCT03244514
org study id: 07-AnIt-16
nct id: NCT03244514
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is no specific therapy for acute kidney injury. It is presumed that supportive measures
      improve the care and outcome of patients with acute kidney injury.

      The investigators hypothesize that the implementation of a bundle of supportive measures
      adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.

      A Randomized prospective multicenter trial is needed to investigate whether the
      implementation of the bundle of measures is effective to prevent AKI in high risk patients
      undergoing cardiac surgery. In this feasibility trial the investigators will analyze the
      compliance rate to the trial protocol in a multicenter, multinational cohort in preparation
      for a large randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Compliance rate
time frame: 48 hours after start of intervention
description: proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time
measure: Occurence of AKI
time frame: 72 hours after start of intervention
measure: Moderate and severe AKI
time frame: 72 hours after start of intervention
measure: Free-days through of vasoactive medications and mechanical ventilation
time frame: 28 days after start of intervention
measure: Renal recovery
time frame: 90 days after start of intervention
description: renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)
measure: Mortality
time frame: 90 days after start of intervention
measure: ICU and hospital stay
time frame: up to 1 year after start of intervention (until discharge)
measure: Number of patients with renal replacement therapy
time frame: 90 days after start of intervention
arm group label: Intervention group
arm group type: Experimental
description: Implementation of the cardiovascular surgery AKI bundle
discontinuation of all nephrotoxic agents when possible
optimization of volume status and hemodynamic parameters
close monitoring of serum creatinine, fluid balance and urinary output
avoidance of hyperglycemia
considerations of alternatives to radiocontrast agents
discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period
avoidance of HES, gelatin, and chlorid-rich solutions
arm group label: Control group
arm group type: No Intervention
description: The patients will receive standard of care (according to each center)
intervention type: Other
intervention name: Intervention
description: Implementation of the cardiovascular AKI bundle (see arm description)
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Zarbock, PhD
role: Study Chair
affiliation: University Hospital Muenster, Dept. of Anesthesiology
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: Italy
country: Spain
country: United Kingdom
citation: Meersch M, Schmidt C, Hoffmeier A, Van Aken H, Wempe C, Gerss J, Zarbock A. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1551-1561. doi: 10.1007/s00134-016-4670-3. Epub 2017 Jan 21. Erratum In: Intensive Care Med. 2017 Mar 7;:
PMID: 28110412
responsible party type: Sponsor
mesh term: Acute Kidney Injury
sharing ipd: No