<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/NCT03830450</url>
  </required_header>
  <id_info>
    <org_study_id>University North</org_study_id>
    <nct_id>NCT03830450</nct_id>
  </id_info>
  <brief_title>Biomarkers of Acute Kidney Injury in Cardiac Surgery</brief_title>
  <acronym>AKIrisk</acronym>
  <official_title>Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nikola Bradic, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Dubrava</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>
      Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery.&#xD;
      An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable&#xD;
      indicator of AKI risk. Because of that, today different biomarkers are investigated to&#xD;
      predict incidence for development AKI after cardiac surgery. This investigation will try to&#xD;
      find potentially risk patients for developing AKI after cardiac surgery by using conventional&#xD;
      markers (creatinine, glomerular filtration rate) in perioperative period comparing with two&#xD;
      different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth&#xD;
      differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk&#xD;
      for AKI development.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)</measure>
    <time_frame>One year</time_frame>
    <description>By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consecutive values of growth differentiation factor 15 (GDF-15)</measure>
    <time_frame>One year</time_frame>
    <description>By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consecutive values of glomerular filtration rate (GFR)</measure>
    <time_frame>One Year</time_frame>
    <description>By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Kidney Injury (Nontraumatic)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous known renal disease&#xD;
&#xD;
          -  patients on chronic dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nikola Bradic, MD</last_name>
    <phone>+385 91 589 3480</phone>
    <email>nbradic@kbd.hr</email>
  </overall_contact>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Dubrava</investigator_affiliation>
    <investigator_full_name>Nikola Bradic, MD</investigator_full_name>
    <investigator_title>MD, Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>Acute kidney injury</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>NGAL</keyword>
  <keyword>GDF-15</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>
  <!-- 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/NCT03830450
org study id: University North
nct id: NCT03830450
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery.
      An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable
      indicator of AKI risk. Because of that, today different biomarkers are investigated to
      predict incidence for development AKI after cardiac surgery. This investigation will try to
      find potentially risk patients for developing AKI after cardiac surgery by using conventional
      markers (creatinine, glomerular filtration rate) in perioperative period comparing with two
      different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth
      differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk
      for AKI development.
observational model: Cohort
time perspective: Prospective
measure: Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)
time frame: One year
description: By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI
measure: Consecutive values of growth differentiation factor 15 (GDF-15)
time frame: One year
description: By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI
measure: Consecutive values of glomerular filtration rate (GFR)
time frame: One Year
description: By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nikola Bradic, MD
phone: +385 91 589 3480
email: nbradic@kbd.hr
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital Dubrava
investigator full name: Nikola Bradic, MD
investigator title: MD, Senior Lecturer
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries