<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/NCT04412980</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0121</org_study_id>
    <nct_id>NCT04412980</nct_id>
  </id_info>
  <brief_title>Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD</brief_title>
  <acronym>MagiCC</acronym>
  <official_title>Importance of Ionized Magnesium Measurement for Monitoring of Continuous Venovenous Haemodialysis With Citrate Anticoagulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novamedica Laboratories</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      It has been reported in several studies that ionized hypomagnesemia is associated with higher&#xD;
      morbidity and mortality rates. During continuous renal replacement therapy with regional&#xD;
      citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered&#xD;
      by magnesium concentration in ordinary dialysis fluid. This may lead to ionized&#xD;
      hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring&#xD;
      CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium&#xD;
      monitoring could be of interest. This study aim to assess the incidence of ionized&#xD;
      hypomagnesemia induced by CRRT-RCA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>assess the systemic ionized magnesemia change after 24h of CRRTsystemic variations of iMg</measure>
    <time_frame>Day 0 and Day 1</time_frame>
    <description>assess the systemic ionized magnesemia change after 24h of CRRT wiith regional citrate anticoagulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with heart rhythm disturbances</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of patients with heart rhythm disturbances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of morbidity and mortality</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of morbidity and mortality</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Intensive Care Unit Syndrome</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      NC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to the ICU and requiring CRRT-RCA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Consecutive patients admitted to the ICU and requiring continuous renal replacement&#xD;
             therapy with regional citrate anticoagulation&#xD;
&#xD;
          -  age &gt; 18 ans&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Persons under protection&#xD;
&#xD;
          -  Paritcipation rejections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romaric Larcher, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>UH Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA)</keyword>
  <keyword>Ionized hypomagnesemia</keyword>
  <keyword>Monitoring of ionized magnesemia</keyword>
  <keyword>Morbi-moratlity</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04412980
org study id: RECHMPL20_0121
nct id: NCT04412980
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has been reported in several studies that ionized hypomagnesemia is associated with higher
      morbidity and mortality rates. During continuous renal replacement therapy with regional
      citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered
      by magnesium concentration in ordinary dialysis fluid. This may lead to ionized
      hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring
      CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium
      monitoring could be of interest. This study aim to assess the incidence of ionized
      hypomagnesemia induced by CRRT-RCA.
observational model: Cohort
time perspective: Prospective
measure: assess the systemic ionized magnesemia change after 24h of CRRTsystemic variations of iMg
time frame: Day 0 and Day 1
description: assess the systemic ionized magnesemia change after 24h of CRRT wiith regional citrate anticoagulation
measure: Proportion of patients with heart rhythm disturbances
time frame: 1 day
description: Proportion of patients with heart rhythm disturbances
measure: Assessment of morbidity and mortality
time frame: 1 day
description: Assessment of morbidity and mortality
NC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Romaric Larcher, MD PhD
role: Study Director
affiliation: UH Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC