<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/NCT02194569</url>
  </required_header>
  <id_info>
    <org_study_id>CIDOUT</org_study_id>
    <nct_id>NCT02194569</nct_id>
  </id_info>
  <brief_title>Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.</brief_title>
  <official_title>Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziekenhuis Oost-Limburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale:&#xD;
&#xD;
      A higher citrate dose during continuous venovenous hemofiltration provides better&#xD;
      anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic&#xD;
      limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a&#xD;
      negative magnesium balance is unwanted.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      Aim of this study is to determine the magnesium balance of citrate-based continuous&#xD;
      veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium&#xD;
      balance depends on citrate dose.&#xD;
&#xD;
      Study design and methods:&#xD;
&#xD;
      A prospective randomized study conducted in critically ill patients with acute kidney injury&#xD;
      (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter)&#xD;
      or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a&#xD;
      postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL&#xD;
      (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in&#xD;
      the patient are tested for the following variables:&#xD;
&#xD;
      (0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca&#xD;
      (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and&#xD;
      creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the&#xD;
      time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24&#xD;
      hrs or at protocol exit.&#xD;
&#xD;
      Sample sites: arterial line, postfilter port (after postdilution and calcium compensation),&#xD;
      effluent sample. All flow rates to be noted.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Twenty patients admitted to intensive care, requiring continuous renal replacement therapy&#xD;
      (CRRT) for AKI.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat&#xD;
      (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both&#xD;
      regimens are within standard protocolled CVVH treatment in the intensive care department.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mg balance of CVVH treatment</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Critically Ill</condition>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>High citrate group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood flow according to weight.Target citrate concentration is 4,5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 0.8-1.1 mg/dL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low citrate group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood flow according to weight. Target citrate concentration is 2.5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 1.3-1.6 mg/dL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Citrate</intervention_name>
    <arm_group_label>High citrate group</arm_group_label>
    <arm_group_label>Low citrate group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients requiring CRRT for AKI (RIFLE criteria)&#xD;
&#xD;
          -  Written informed consent from the patient or legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-existing chronic renal insufficiency requiring dialysis&#xD;
&#xD;
          -  chronic immunosuppression&#xD;
&#xD;
          -  liver cirrhosis Child-Pugh C&#xD;
&#xD;
          -  severe or shock-related hepatitis&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Willem Boer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ziekenhuis Oost-Limburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziekenhuis Oost Limburg</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>March 29, 2018</last_update_submitted>
  <last_update_submitted_qc>March 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziekenhuis Oost-Limburg</investigator_affiliation>
    <investigator_full_name>Willem Boer</investigator_full_name>
    <investigator_title>MD</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>Critical Illness</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/NCT02194569
org study id: CIDOUT
nct id: NCT02194569
lead sponsor: 
has dmc: No
Rationale:

      A higher citrate dose during continuous venovenous hemofiltration provides better
      anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic
      limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a
      negative magnesium balance is unwanted.

      Objective:

      Aim of this study is to determine the magnesium balance of citrate-based continuous
      veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium
      balance depends on citrate dose.

      Study design and methods:

      A prospective randomized study conducted in critically ill patients with acute kidney injury
      (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter)
      or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a
      postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL
      (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in
      the patient are tested for the following variables:

      (0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca
      (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and
      creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the
      time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24
      hrs or at protocol exit.

      Sample sites: arterial line, postfilter port (after postdilution and calcium compensation),
      effluent sample. All flow rates to be noted.

      Study population:

      Twenty patients admitted to intensive care, requiring continuous renal replacement therapy
      (CRRT) for AKI.

      Intervention:

      Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat
      (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both
      regimens are within standard protocolled CVVH treatment in the intensive care department.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mg balance of CVVH treatment
time frame: 1 month
arm group label: High citrate group
arm group type: Experimental
description: Blood flow according to weight.Target citrate concentration is 4,5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 0.8-1.1 mg/dL.
arm group label: Low citrate group
arm group type: Experimental
description: Blood flow according to weight. Target citrate concentration is 2.5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 1.3-1.6 mg/dL.
intervention type: Drug
intervention name: Citrate
arm group label: High citrate group
arm group label: Low citrate group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Willem Boer, MD
role: Principal Investigator
affiliation: Ziekenhuis Oost-Limburg
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Ziekenhuis Oost-Limburg
investigator full name: Willem Boer
investigator title: MD
mesh term: Acute Kidney Injury
mesh term: Critical Illness