<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/NCT02991742</url>
  </required_header>
  <id_info>
    <org_study_id>58593116.2.0000.5462</org_study_id>
    <nct_id>NCT02991742</nct_id>
  </id_info>
  <brief_title>Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients (IDPC Trial)</brief_title>
  <acronym>IDPC</acronym>
  <official_title>Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients After Diagnostic and Therapeutic Cardiac Catheterization (IDPC Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Dante Pazzanese de Cardiologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Dante Pazzanese de Cardiologia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contrast media-induced nephropathy following diagnostic and therapeutic cardiac&#xD;
      catheterization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrast-induced acute kidney injury represents a serious complication of procedures&#xD;
      requiring administration of iodinated contrast media and is associated with the need for&#xD;
      dialysis, prolonged hospitalization, increased costs, and mortality.&#xD;
&#xD;
      Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the&#xD;
      procedure.&#xD;
&#xD;
      Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than&#xD;
      low-osmolar contrast media in high-risk patients.&#xD;
&#xD;
      The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients&#xD;
      between 48 and 96 hours after procedures that use contrast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Contrast-induced nephropathy incidence</measure>
    <time_frame>Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization</measure>
    <time_frame>30 days</time_frame>
    <description>Need for dialysis when patient develop end stage kidney failure -- by the time patient lose about 85 to 90 percent of your kidney function and have a glomerular filtration rate of &lt;15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The individual components of the combined outcome (total mortality or dialysis indication)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2262</enrollment>
  <condition>Acute Kidney Failure</condition>
  <arm_group>
    <arm_group_label>Iodixanol</arm_group_label>
    <description>Iodixanol contrast media</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ioxaglate</arm_group_label>
    <description>Ioxaglate contrast media</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>contrast media</intervention_name>
    <description>Compare 2 contrast media</description>
    <arm_group_label>Iodixanol</arm_group_label>
    <arm_group_label>Ioxaglate</arm_group_label>
    <other_name>Iodixanol X Ioxaglate</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing coronary angiography or percutaneous interventions will be eligible for&#xD;
        the trial if they have at least 1 risk factor for contrast-induced acute kidney injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        At least one of the following criteria&#xD;
&#xD;
          -  Aged more than 70 years-old&#xD;
&#xD;
          -  Chronic renal failure&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Congestive heart failure - left ventricular ejection fraction &lt; 0.50&#xD;
&#xD;
          -  Shock or intra-aortic ballon pump use&#xD;
&#xD;
          -  Urgency or emergency procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in dialysis&#xD;
&#xD;
          -  Allergy to iodine&#xD;
&#xD;
          -  Patient refusal to informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Dante Pazzanese de Cardiologia</investigator_affiliation>
    <investigator_full_name>RAFAELA ANDRADE PENALVA FREITAS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>nephropathy</keyword>
  <keyword>catheterization</keyword>
  <keyword>contrast media</keyword>
  <keyword>ioxaglate</keyword>
  <keyword>iodixanol</keyword>
  <keyword>high risk</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <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/NCT02991742
org study id: 58593116.2.0000.5462
nct id: NCT02991742
lead sponsor: 
has dmc: Yes
Contrast media-induced nephropathy following diagnostic and therapeutic cardiac
      catheterization.
Contrast-induced acute kidney injury represents a serious complication of procedures
      requiring administration of iodinated contrast media and is associated with the need for
      dialysis, prolonged hospitalization, increased costs, and mortality.

      Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the
      procedure.

      Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than
      low-osmolar contrast media in high-risk patients.

      The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients
      between 48 and 96 hours after procedures that use contrast.
observational model: Cohort
time perspective: Prospective
measure: Contrast-induced nephropathy incidence
time frame: Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization
measure: Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization
time frame: 30 days
description: Need for dialysis when patient develop end stage kidney failure -- by the time patient lose about 85 to 90 percent of your kidney function and have a glomerular filtration rate of <15.
measure: The individual components of the combined outcome (total mortality or dialysis indication)
time frame: 30 days
arm group label: Iodixanol
description: Iodixanol contrast media
arm group label: Ioxaglate
description: Ioxaglate contrast media
intervention type: Other
intervention name: contrast media
description: Compare 2 contrast media
arm group label: Iodixanol
arm group label: Ioxaglate
other name: Iodixanol X Ioxaglate
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Instituto Dante Pazzanese de Cardiologia
investigator full name: RAFAELA ANDRADE PENALVA FREITAS
investigator title: Principal Investigator
mesh term: Kidney Diseases
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury
sharing ipd: Undecided