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/NCT05989971</url>
    </required_header>
    <id_info>
      <org_study_id>20230731</org_study_id>
      <nct_id>NCT05989971</nct_id>
    </id_info>
    <brief_title>The Effect of Continuous Renal Replacement Therapy on the Efficiency of Extracorporeal CO2 Removal</brief_title>
    <official_title>The Effect of Continuous Renal Replacement Therapy on the Efficiency of Extracorporeal CO2 Removal</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Southeast University, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Southeast University, China</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>
        In the design of extracorporeal carbon dioxide removal (ECCO2R) combined with continuous&#xD;
        renal replacement therapy (CRRT) equipment, in model of continuous veno-venous hemofiltration&#xD;
        (CVVH) , the HCO3- concentration in the pre membrane lung blood is diluted by the replacement&#xD;
        solution, and a decrease in HCO3- leads to a decrease in PCO2. On the other hand, in&#xD;
        continuous veno-venous hemodialysis (CVVHD), HCO3- in post membrane blood will exchange&#xD;
        interaction. The exchange results of HCO3- determine the impact of CVVHD on the CO2 removal&#xD;
        efficiency of the ECCO2R combined CRRT system. This study aims to investigate the effects of&#xD;
        CVVH and CVVHD on in vitro CO2 clearance efficiency.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the design of extracorporeal carbon dioxide removal (ECCO2R) combined with continuous&#xD;
        renal replacement therapy (CRRT) equipment, the pre dilution replacement solution for&#xD;
        continuous veno-venous hemofiltration (CVVH) enters the extracorporeal bloodstream upstream&#xD;
        of the membrane lung, so the HCO3- concentration in the pre membrane lung blood is diluted by&#xD;
        the replacement solution. HCO3- and dissolved CO2 are in a dynamic and rapid equilibrium&#xD;
        state, and a decrease in HCO3- leads to a decrease in PCO2. On the other hand, in continuous&#xD;
        veno-venous hemodialysis (CVVHD), the blood after the membrane needs to undergo material&#xD;
        exchange with the dialysate through a filter. The dialysate is usually HCO3- with normal&#xD;
        plasma concentration, so HCO3- in post membrane blood will exchange interaction. The exchange&#xD;
        results of HCO3- determine the impact of CVVHD on the CO2 removal efficiency of the ECCO2R&#xD;
        combined CRRT system. This study aims to investigate the effects of CVVH and CVVHD on in&#xD;
        vitro CO2 clearance efficiency.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 24, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>extracorporeal CO2 removal rate</measure>
      <time_frame>after 30min of continuous renal replacement therapy</time_frame>
      <description>extracorporeal CO2 removal rate was calculated as the difference of total CO2 content before membrane lung and after hemofilter, and normalized to an inlet PCO2 of 45 mmHg</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Respiratory Failure With Hypercapnia</condition>
    <arm_group>
      <arm_group_label>Extracorporeal carbon dioxide removal combined with continuous renal replacement therapy</arm_group_label>
      <description>extracorporeal carbon dioxide removal combined with continuous veno-venous hemofiltration or continuous veno-venous hemodialysis.CVVH and CVVHD set-up: predilution 30 ml/kg/h, dialysate dose 30 ml/kg/h, ultrafiltration rate was equal to the total rate of substitution fluid infusion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>continuous renal replacement therapy</intervention_name>
      <description>continuous veno-venous hemofiltration or continuous veno-venous hemodialysis set-up: predilution 30 ml/kg/h, dialysate dose 30 ml/kg/h, ultrafiltration rate was equal to the total rate of substitution fluid infusion</description>
      <arm_group_label>Extracorporeal carbon dioxide removal combined with continuous renal replacement therapy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          using Extracorporeal carbon dioxide removal combined with continuous renal replacement&#xD;
          therapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Using Extracorporeal carbon dioxide removal combined with continuous renal replacement&#xD;
               therapy&#xD;
  &#xD;
            -  18 years ≤ age ≤ 85 years;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe hemodynamic instability (increased dosage of vasoactive drugs or MAP ≤ 65mmHg&#xD;
               within two hours);&#xD;
  &#xD;
            -  Severe electrolyte deficiency (including severe hyponatremia (blood sodium&lt;130mmol/L)&#xD;
               and hypokalemia (blood potassium&lt;3.0mmol/L));&#xD;
  &#xD;
            -  Participate in other intervention studies within 30 days;&#xD;
  &#xD;
            -  Do not consent this research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ling Liu</last_name>
      <role>Study Director</role>
      <affiliation>Zhongda Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ling Liu</last_name>
      <phone>+86 13851435472</phone>
      <email>liulingdoctor@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ling Liu</last_name>
      <phone>+86 13851435472</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ling Liu</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210009</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ling Liu</last_name>
        <phone>+8613851435472</phone>
        <phone_ext>+8613851435472</phone_ext>
        <email>liulingdoctor@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Southeast University, China</investigator_affiliation>
      <investigator_full_name>Ling Liu</investigator_full_name>
      <investigator_title>deputy director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
      <mesh_term>Hypercapnia</mesh_term>
    </condition_browse>
    <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/NCT05989971
  org study id: 20230731
  nct id: NCT05989971
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In the design of extracorporeal carbon dioxide removal (ECCO2R) combined with continuous
        renal replacement therapy (CRRT) equipment, in model of continuous veno-venous hemofiltration
        (CVVH) , the HCO3- concentration in the pre membrane lung blood is diluted by the replacement
        solution, and a decrease in HCO3- leads to a decrease in PCO2. On the other hand, in
        continuous veno-venous hemodialysis (CVVHD), HCO3- in post membrane blood will exchange
        interaction. The exchange results of HCO3- determine the impact of CVVHD on the CO2 removal
        efficiency of the ECCO2R combined CRRT system. This study aims to investigate the effects of
        CVVH and CVVHD on in vitro CO2 clearance efficiency.
  In the design of extracorporeal carbon dioxide removal (ECCO2R) combined with continuous
        renal replacement therapy (CRRT) equipment, the pre dilution replacement solution for
        continuous veno-venous hemofiltration (CVVH) enters the extracorporeal bloodstream upstream
        of the membrane lung, so the HCO3- concentration in the pre membrane lung blood is diluted by
        the replacement solution. HCO3- and dissolved CO2 are in a dynamic and rapid equilibrium
        state, and a decrease in HCO3- leads to a decrease in PCO2. On the other hand, in continuous
        veno-venous hemodialysis (CVVHD), the blood after the membrane needs to undergo material
        exchange with the dialysate through a filter. The dialysate is usually HCO3- with normal
        plasma concentration, so HCO3- in post membrane blood will exchange interaction. The exchange
        results of HCO3- determine the impact of CVVHD on the CO2 removal efficiency of the ECCO2R
        combined CRRT system. This study aims to investigate the effects of CVVH and CVVHD on in
        vitro CO2 clearance efficiency.
  observational model: Cohort
  time perspective: Prospective
  measure: extracorporeal CO2 removal rate
  time frame: after 30min of continuous renal replacement therapy
  description: extracorporeal CO2 removal rate was calculated as the difference of total CO2 content before membrane lung and after hemofilter, and normalized to an inlet PCO2 of 45 mmHg
  arm group label: Extracorporeal carbon dioxide removal combined with continuous renal replacement therapy
  description: extracorporeal carbon dioxide removal combined with continuous veno-venous hemofiltration or continuous veno-venous hemodialysis.CVVH and CVVHD set-up: predilution 30 ml/kg/h, dialysate dose 30 ml/kg/h, ultrafiltration rate was equal to the total rate of substitution fluid infusion.
  intervention type: Other
  intervention name: continuous renal replacement therapy
  description: continuous veno-venous hemofiltration or continuous veno-venous hemodialysis set-up: predilution 30 ml/kg/h, dialysate dose 30 ml/kg/h, ultrafiltration rate was equal to the total rate of substitution fluid infusion
  arm group label: Extracorporeal carbon dioxide removal combined with continuous renal replacement therapy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Ling Liu
  role: Study Director
  affiliation: Zhongda Hospital
  last name: Ling Liu
  phone: +86 13851435472
  email: liulingdoctor@126.com
  last name: Ling Liu
  phone: +86 13851435472
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Southeast University, China
  investigator full name: Ling Liu
  investigator title: deputy director
  mesh term: Respiratory Insufficiency
  mesh term: Hypercapnia
  sharing ipd: No