<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/NCT04445779</url>
  </required_header>
  <id_info>
    <org_study_id>28878529</org_study_id>
    <nct_id>NCT04445779</nct_id>
  </id_info>
  <brief_title>Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction</brief_title>
  <acronym>PREKARKID-10</acronym>
  <official_title>Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Hospital Center, Split</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Hospital Center, Split</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>
      Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a&#xD;
      co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of&#xD;
      improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce&#xD;
      the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is&#xD;
      major risk factor for acute kidney injury/failure (AKI/F).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in serum creatinine after cardiac surgery indicating kidney injury.</measure>
    <time_frame>7 days</time_frame>
    <description>Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury.</measure>
    <time_frame>3 days</time_frame>
    <description>Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily urine output during the 72 hours postoperatively.</measure>
    <time_frame>3 days</time_frame>
    <description>Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay in intensive care unit</measure>
    <time_frame>10 days</time_frame>
    <description>Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Advanced glycation endproducts</measure>
    <time_frame>7 days</time_frame>
    <description>Elevated advanced glycation endproducts (AGE) in skin, measured using skin autofluorescence, are reliable predictors of cardiovascular disease and diabetes mellitus. Elevated levels before cardiac surgery should also predict increased risk of intraoperative morbidity, mortality and postoperative complications.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Acute Kidney Failure</condition>
  <arm_group>
    <arm_group_label>CoQ10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in the form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before the surgical procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive per-orally placebo in three divided doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Coenzyme Q10</intervention_name>
    <description>Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before surgical procedure.</description>
    <arm_group_label>CoQ10</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled for elective cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients receiving high dose vitamin B supplementation (defined as more that 200% of&#xD;
             recommended daily allowances)&#xD;
&#xD;
          -  patients under warfarin therapy&#xD;
&#xD;
          -  urgent surgery&#xD;
&#xD;
          -  end stage kidney disease&#xD;
&#xD;
          -  therapy with multiple nephrotoxic drugs&#xD;
&#xD;
          -  chronic kidney disease&#xD;
&#xD;
          -  obstructive uropathy&#xD;
&#xD;
          -  previous cardiac surgery procedure&#xD;
&#xD;
          -  alcohol abuse&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  allergy to any ingredient of Myoqinon capsule&#xD;
&#xD;
          -  patients receiving Myoqinon and fail to demonstrate a significant increase in blood&#xD;
             concentration of Q10&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hrvoje Vučemilović, MD</last_name>
    <phone>00385914444032</phone>
    <email>hrvoje.vucemilovic@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Hospital Center Split</name>
      <address>
        <city>Split</city>
        <state>Splitsko Dalmatinska Županija</state>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hrvoje Vučemilović, MD</last_name>
      <phone>00 385 91 4444 032</phone>
      <email>hrvoje.vucemilovic@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Hospital Center, Split</investigator_affiliation>
    <investigator_full_name>Hrvoje Vučemilović</investigator_full_name>
    <investigator_title>Hrvoje Vučemilović, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ubiquinone</mesh_term>
    <mesh_term>Coenzyme Q10</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04445779
org study id: 28878529
nct id: NCT04445779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a
      co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of
      improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce
      the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is
      major risk factor for acute kidney injury/failure (AKI/F).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Difference in serum creatinine after cardiac surgery indicating kidney injury.
time frame: 7 days
description: Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury.
measure: Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury.
time frame: 3 days
description: Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.
measure: Daily urine output during the 72 hours postoperatively.
time frame: 3 days
description: Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.
measure: Length of stay in intensive care unit
time frame: 10 days
description: Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial.
measure: Advanced glycation endproducts
time frame: 7 days
description: Elevated advanced glycation endproducts (AGE) in skin, measured using skin autofluorescence, are reliable predictors of cardiovascular disease and diabetes mellitus. Elevated levels before cardiac surgery should also predict increased risk of intraoperative morbidity, mortality and postoperative complications.
arm group label: CoQ10
arm group type: Experimental
description: Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in the form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before the surgical procedure.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive per-orally placebo in three divided doses.
intervention type: Dietary Supplement
intervention name: Coenzyme Q10
description: Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before surgical procedure.
arm group label: CoQ10
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Hrvoje Vučemilović, MD
phone: 00385914444032
email: hrvoje.vucemilovic@gmail.com
facility: 
status: Recruiting
contact: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: Clinical Hospital Center, Split
investigator full name: Hrvoje Vučemilović
investigator title: Hrvoje Vučemilović, Principal Investigator
mesh term: Acute Kidney Injury
mesh term: Renal Insufficiency
mesh term: Ubiquinone
mesh term: Coenzyme Q10