xml: <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/NCT06021080</url>
    </required_header>
    <id_info>
      <org_study_id>HChen</org_study_id>
      <nct_id>NCT06021080</nct_id>
    </id_info>
    <brief_title>Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions</brief_title>
    <official_title>Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Provincial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Provincial Hospital</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>
        It is unclear whether different modes of continuous renal replacement therapy (CRRT) impact&#xD;
        post-filter ionized calcium concentrations during regional citrate anticoagulation (RCA) when&#xD;
        using calcium-containing replacement fluid.&#xD;
  &#xD;
        This prospective, single-center, observational cohort study will screen all patients&#xD;
        receiving CRRT for eligibility. General clinical information will be collected before&#xD;
        commencing CRRT treatment. Patients will be randomly assigned to either the veno-venous&#xD;
        hemofiltration (CVVH) or continuous veno-venous hemodialysis (CVVHD) group and switch to the&#xD;
        alternative mode in the subsequent treatment session. Pre-filter and post-filter ionized&#xD;
        calcium, systemic total and ionized calcium, and effluent total and ionized calcium will be&#xD;
        measured 2 hours after the initiation of CRRT. Electrolyte levels, arterial blood gases,&#xD;
        hourly citrate dose, and total citrate dose will be recorded every 6 hours until the end of&#xD;
        CRRT. The primary outcome is the difference in ionized calcium concentrations at each site&#xD;
        over time between the two modes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 9, 2023</start_date>
    <completion_date type="Anticipated">December 9, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 9, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>Post-filter iCa</measure>
      <time_frame>2 hours after the initiation of CRRT</time_frame>
      <description>The post-filter ionized calcium concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum iCa</measure>
      <time_frame>2 hours after the initiation of CRRT</time_frame>
      <description>Serum ionized calcium concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum Ca2+</measure>
      <time_frame>2 hours after the initiation of CRRT</time_frame>
      <description>Serum total calcium concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effluent Ca2+</measure>
      <time_frame>2 hours after the initiation of CRRT</time_frame>
      <description>Effluent total calcium concentration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of new-onset metabolic complications</measure>
      <time_frame>48 hours after the initiation of CRRT</time_frame>
      <description>Including hypercalcemia, hypocalcemia, metabolic acidosis, metabolic alkalosis, citrate accumulation, hypernatremia, and hyponatremia</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Renal Injury</condition>
    <condition>Regional Citrate Anticoagulation</condition>
    <condition>Continuous Renal Replacement Therapy</condition>
    <arm_group>
      <arm_group_label>CVVHD</arm_group_label>
      <description>Continuous Veno-Venous Hemosdialysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CVVH</arm_group_label>
      <description>Continuous Veno-Venous Hemofiltration</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          All patients admitted to the ICU who need RCA-CRRT will be screened for study eligibility.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1) Age ≥ 18 years old; 2) Receiving citrate anticoagulation; 3) Obtain Informed consent&#xD;
          from patients or next of kin.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1) Pregnant or lactating women; 2) Allergic to citrate anticoagulants; 3) Severe liver&#xD;
          dysfunction (total bilirubin levels exceeding two times the normal range); 4) Hypoxemia&#xD;
          (PaO2 &lt; 60 mmHg); 5) Inadequate tissue perfusion (blood pressure &lt; 90/60 mmHg despite high&#xD;
          doses of vasoactive agents); 6) Hyperlactatemia (lactate&gt; 4 mmol/L); 7) Hypernatremia; 8)&#xD;
          Estimated length of hospital stay &lt; 48h; 9) Participated in other studies.&#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>Han Chen, Ph.D., M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian Provincial Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Han Chen, Ph.D., M.D.</last_name>
      <phone>+86 591 88217010</phone>
      <email>hanchen.cn@icloud.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wan-Li Yan, M.D.</last_name>
      <phone>+86 591 88217011</phone>
      <email>1727731759@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fujian Provincial Hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fa-Yang Lian, M.D.</last_name>
        <phone>+86 591 88216023</phone>
        <email>flsykyk@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
      <investigator_full_name>Han Chen</investigator_full_name>
      <investigator_title>Deputy chief physician</investigator_title>
    </responsible_party>
    <keyword>Renal Injury</keyword>
    <keyword>Regional citrate anticoagulation</keyword>
    <keyword>Continuous renal replacement therapy</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021080
  org study id: HChen
  nct id: NCT06021080
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  It is unclear whether different modes of continuous renal replacement therapy (CRRT) impact
        post-filter ionized calcium concentrations during regional citrate anticoagulation (RCA) when
        using calcium-containing replacement fluid.
  
        This prospective, single-center, observational cohort study will screen all patients
        receiving CRRT for eligibility. General clinical information will be collected before
        commencing CRRT treatment. Patients will be randomly assigned to either the veno-venous
        hemofiltration (CVVH) or continuous veno-venous hemodialysis (CVVHD) group and switch to the
        alternative mode in the subsequent treatment session. Pre-filter and post-filter ionized
        calcium, systemic total and ionized calcium, and effluent total and ionized calcium will be
        measured 2 hours after the initiation of CRRT. Electrolyte levels, arterial blood gases,
        hourly citrate dose, and total citrate dose will be recorded every 6 hours until the end of
        CRRT. The primary outcome is the difference in ionized calcium concentrations at each site
        over time between the two modes.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Post-filter iCa
  time frame: 2 hours after the initiation of CRRT
  description: The post-filter ionized calcium concentration
  measure: Serum iCa
  time frame: 2 hours after the initiation of CRRT
  description: Serum ionized calcium concentration
  measure: Serum Ca2+
  time frame: 2 hours after the initiation of CRRT
  description: Serum total calcium concentration
  measure: Effluent Ca2+
  time frame: 2 hours after the initiation of CRRT
  description: Effluent total calcium concentration
  measure: Incidence of new-onset metabolic complications
  time frame: 48 hours after the initiation of CRRT
  description: Including hypercalcemia, hypocalcemia, metabolic acidosis, metabolic alkalosis, citrate accumulation, hypernatremia, and hyponatremia
  arm group label: CVVHD
  description: Continuous Veno-Venous Hemosdialysis
  arm group label: CVVH
  description: Continuous Veno-Venous Hemofiltration
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Han Chen, Ph.D., M.D.
  role: Principal Investigator
  affiliation: Fujian Provincial Hospital
  last name: Han Chen, Ph.D., M.D.
  phone: +86 591 88217010
  email: hanchen.cn@icloud.com
  last name: Wan-Li Yan, M.D.
  phone: +86 591 88217011
  email: 1727731759@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fujian Provincial Hospital
  investigator full name: Han Chen
  investigator title: Deputy chief physician
  sharing ipd: No