<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/NCT03227835</url>
  </required_header>
  <id_info>
    <org_study_id>METC 2017-0058</org_study_id>
    <nct_id>NCT03227835</nct_id>
  </id_info>
  <brief_title>Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold</brief_title>
  <acronym>CINART</acronym>
  <official_title>Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</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>
      After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy&#xD;
      (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is&#xD;
      associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI,&#xD;
      therefore the focus lies on prevention. Clinical practice guidelines for the prevention of&#xD;
      CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume&#xD;
      expansion with normal saline is recommended as prophylaxis.&#xD;
&#xD;
      Earlier this year the results of the AMACING study (A MAastricht Contrast-Induced Nephropathy&#xD;
      Guideline study) were published in The Lancet (NL47173.068.14/METC 14-2-006; Clinical&#xD;
      Trials.gov NCT02106234;&#xD;
      http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These&#xD;
      results show that for the greater part (&gt;90%) of patients considered to be at risk of&#xD;
      CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard&#xD;
      intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard&#xD;
      prophylactic hydration confers some risk (5.5% complications of intravenous hydration were&#xD;
      recorded in the AMACING study).&#xD;
&#xD;
      As a result the clinical protocol in the Maastricht University Medical Centre (MUMC+) has&#xD;
      been adapted, and patients with an estimated Glomerular Filtration Rate (eGFR)&#xD;
      &gt;29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after&#xD;
      procedures with intravascular iodinated contrast material administration.&#xD;
&#xD;
      CINART is a one year prospective observational study with the aim to evaluate the&#xD;
      consequences of the protocol change for 1. for incidences of CIN/CI-AKI, dialysis and&#xD;
      mortality, 2. for clinical practice in terms of patient burden (complications of&#xD;
      prophylaxis), hospital burden (extra hospitalisations for prophylaxis), and costs, as derived&#xD;
      from the number of elective procedures carried out in patients formerly eligible for&#xD;
      prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Number of procedures</measure>
    <time_frame>1 year</time_frame>
    <description>Number of elective procedures with intravascular contrast in patients formerly eligible for prophylaxis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast-Induced Nephropathy</measure>
    <time_frame>2-6 days post contrast administration</time_frame>
    <description>&gt;25% or &gt;44umol/L increase in serum creatinine from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-month dialysis</measure>
    <time_frame>26-35 days post-contrast</time_frame>
    <description>incidences of dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-month mortality</measure>
    <time_frame>26-35 days post-contrast</time_frame>
    <description>incidences of all-cause mortality</description>
  </secondary_outcome>
  <enrollment type="Actual">1372</enrollment>
  <condition>Contrast-induced Nephropathy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intravascular iodinated contrast material administration</intervention_name>
    <description>Evaluation of the consequences of the protocol change to not giving prophylaxis to patients with an eGFR &gt;29mL/min/1.73m2</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at risk of CIN/CIAKI according to the guidelines and an eGFR between&#xD;
        30-59mL/min/1.73m2, who are referred for an elective procedure with intravascular iodinated&#xD;
        contrast administration at the MUMC+ after the protocol change i.e. the threshold for&#xD;
        prophylactic intravenous hydration has been lowered to eGFR&lt;30mL/min/1.73m2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  referred for an elective procedure with intravascular iodinated contrast&#xD;
             administration at Maastricht University Medical Centre&#xD;
&#xD;
          -  eGFR30-44mL/min/1.73m2 OR eGFR45-59mL/min/1.73m2 + DM OR eGFR45-59mL/min/1.73m2 + &gt;1&#xD;
             risk factor (&gt;age &gt;75 years, anaemia, cardiovascular disease, prescribed NSAID or&#xD;
             Diuretic medication) OR multiple myeloma/lymphoplasmacytic lymphoma with small chain&#xD;
             proteinuria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  eGFR&lt;30mL/min/1.73m2&#xD;
&#xD;
          -  Dialysis/renal replacement therapy&#xD;
&#xD;
          -  emergency procedure&#xD;
&#xD;
          -  intensive care patient&#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>JE Wildberger</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht UMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Zuid-Limburg</state>
        <zip>6202AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Nijssen EC, Rennenberg RJ, Nelemans PJ, Essers BA, Janssen MM, Vermeeren MA, Ommen VV, Wildberger JE. Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial. Lancet. 2017 Apr 1;389(10076):1312-1322. doi: 10.1016/S0140-6736(17)30057-0. Epub 2017 Feb 21.</citation>
    <PMID>28233565</PMID>
  </reference>
  <reference>
    <citation>Centraal BegeleidingsOrgaan (CBO). CBO richtlijnen contrast. 2007 Available from: www.cbo.nl/product/richtlijnen/folder20021023121843/rl_jodium_2007</citation>
  </reference>
  <reference>
    <citation>Veligheids Management Systeem. VMS veiligheidsprogramma. Voorkomen van nierinsufficiëntie bij intravasculair gebruik van jodiumhoudende contrastmiddelen. September 2009. 2009 [cited; Available from: http:/www.vmszorg.nl/10- Themas/Nierinsufficientie/Praktijkgids-Nierinsufficientie</citation>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contrast-induced nephropathy</keyword>
  <keyword>contrast-induced acute kidney injury</keyword>
  <keyword>prophylaxis</keyword>
  <keyword>intravenous hydration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</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/NCT03227835
org study id: METC 2017-0058
nct id: NCT03227835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy
      (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is
      associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI,
      therefore the focus lies on prevention. Clinical practice guidelines for the prevention of
      CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume
      expansion with normal saline is recommended as prophylaxis.

      Earlier this year the results of the AMACING study (A MAastricht Contrast-Induced Nephropathy
      Guideline study) were published in The Lancet (NL47173.068.14/METC 14-2-006; Clinical
      Trials.gov NCT02106234;
      http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These
      results show that for the greater part (>90%) of patients considered to be at risk of
      CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard
      intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard
      prophylactic hydration confers some risk (5.5% complications of intravenous hydration were
      recorded in the AMACING study).

      As a result the clinical protocol in the Maastricht University Medical Centre (MUMC+) has
      been adapted, and patients with an estimated Glomerular Filtration Rate (eGFR)
      >29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after
      procedures with intravascular iodinated contrast material administration.

      CINART is a one year prospective observational study with the aim to evaluate the
      consequences of the protocol change for 1. for incidences of CIN/CI-AKI, dialysis and
      mortality, 2. for clinical practice in terms of patient burden (complications of
      prophylaxis), hospital burden (extra hospitalisations for prophylaxis), and costs, as derived
      from the number of elective procedures carried out in patients formerly eligible for
      prophylaxis.
observational model: Cohort
time perspective: Prospective
measure: Number of procedures
time frame: 1 year
description: Number of elective procedures with intravascular contrast in patients formerly eligible for prophylaxis
measure: Contrast-Induced Nephropathy
time frame: 2-6 days post contrast administration
description: >25% or >44umol/L increase in serum creatinine from baseline
measure: 1-month dialysis
time frame: 26-35 days post-contrast
description: incidences of dialysis
measure: 1-month mortality
time frame: 26-35 days post-contrast
description: incidences of all-cause mortality
intervention type: Other
intervention name: intravascular iodinated contrast material administration
description: Evaluation of the consequences of the protocol change to not giving prophylaxis to patients with an eGFR >29mL/min/1.73m2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JE Wildberger
role: Principal Investigator
affiliation: Maastricht UMC
facility: 
country: Netherlands
citation: Nijssen EC, Rennenberg RJ, Nelemans PJ, Essers BA, Janssen MM, Vermeeren MA, Ommen VV, Wildberger JE. Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial. Lancet. 2017 Apr 1;389(10076):1312-1322. doi: 10.1016/S0140-6736(17)30057-0. Epub 2017 Feb 21.
PMID: 28233565
citation: Centraal BegeleidingsOrgaan (CBO). CBO richtlijnen contrast. 2007 Available from: www.cbo.nl/product/richtlijnen/folder20021023121843/rl_jodium_2007
citation: Veligheids Management Systeem. VMS veiligheidsprogramma. Voorkomen van nierinsufficiëntie bij intravasculair gebruik van jodiumhoudende contrastmiddelen. September 2009. 2009 [cited; Available from: http:/www.vmszorg.nl/10- Themas/Nierinsufficientie/Praktijkgids-Nierinsufficientie
responsible party type: Sponsor
mesh term: Kidney Diseases
sharing ipd: No