<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/NCT03791190</url>
  </required_header>
  <id_info>
    <org_study_id>RCA for CRRT in liver failure</org_study_id>
    <nct_id>NCT03791190</nct_id>
  </id_info>
  <brief_title>RCA for CRRT in Liver Failure and High Risk Bleeding Patients</brief_title>
  <official_title>The Efficacy and Safety of Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Patients With Liver Failure and High Risk Bleeding: a Randomized, Control, Open-labeled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this single center, randomized, control, open-labeled study is to evaluate the&#xD;
      effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure&#xD;
      and high risk bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver failure (LF) is a common co-morbidity in critical care patients who need continuous&#xD;
      renal replacement therapy (CRRT). Patients with LF are usually associated with impaired&#xD;
      coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO&#xD;
      guideline recommended no-anticoagulation for CRRT in patients with liver failure and&#xD;
      increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was&#xD;
      reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more&#xD;
      than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure&#xD;
      patients underwent no-anticoagulation CRRT. Several observational studies suggested that&#xD;
      regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with&#xD;
      liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in&#xD;
      patients with liver failure and high bleeding risk are controversial. Therefore, the purpose&#xD;
      of this single center, randomized, control, open-labeled study is to evaluate the effect and&#xD;
      safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk&#xD;
      bleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 6, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Filter failure</measure>
    <time_frame>72 hours</time_frame>
    <description>Filter failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Total Ca2+/ion Ca2+ level</measure>
    <time_frame>2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.</time_frame>
    <description>Serum Total Ca2+/ ionized Ca2+ level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypocalcemia</measure>
    <time_frame>72 hours</time_frame>
    <description>Ionized Ca2+ &lt; 1.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acidosis</measure>
    <time_frame>72 hours</time_frame>
    <description>Blood pH &lt; 7.35</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkalosis</measure>
    <time_frame>72 hours.</time_frame>
    <description>Blood pH &gt; 7.45</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>72 hours</time_frame>
    <description>Bleeding episode during the CRRT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum citrate concentration</measure>
    <time_frame>2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.</time_frame>
    <description>Citrate concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum total bilirubin level</measure>
    <time_frame>Every 24 hours up to 72 hours.</time_frame>
    <description>Total bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum AST level</measure>
    <time_frame>Every 24 hours up to 72 hours.</time_frame>
    <description>AST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum ALT level</measure>
    <time_frame>Every 24 hours up to 72 hours.</time_frame>
    <description>ALT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Liver Failure</condition>
  <arm_group>
    <arm_group_label>No-anticoagulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regional citrate anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.&#xD;
Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+.&#xD;
Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regional citrate anticoagulation</intervention_name>
    <description>Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.</description>
    <arm_group_label>Regional citrate anticoagulation</arm_group_label>
    <other_name>RCA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No-anticoagulation</intervention_name>
    <description>Patients accepted CRRT without anticoagulant.</description>
    <arm_group_label>No-anticoagulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver failure (acute liver failure and chronic liver failure)&#xD;
&#xD;
          -  High bleeding risk&#xD;
&#xD;
          -  Scheduled CRRT treatment&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of other anticoagulants&#xD;
&#xD;
          -  Uncorrectable hypoxemia (PaO2 &lt; 60 mmHg) or systemic hypoperfusion shock&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Fistula, CRRT treatment time &lt; 12 hours&#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>Shiren Sun, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Xijing Hospital, the Fourth Military Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming Bai, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xijing Hospital, the Fourth Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shiren Sun, Doctor</last_name>
    <phone>+8602984775193</phone>
    <email>sunshiren@medmail.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ming Bai, Doctor</last_name>
    <phone>sunshiren@medmail.com.cn</phone>
    <email>mingbai1983@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xijing Hospital of Nephrology</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiren Sun, M.D.</last_name>
      <phone>+8602984775193</phone>
      <email>sunshiren@medmail.com.cn</email>
    </contact>
    <contact_backup>
      <last_name>Ming Bai, M.D.</last_name>
      <phone>+8602984775193</phone>
      <email>mingbai1983@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Shiren Sun, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Shiren sun</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>CRRT</keyword>
  <keyword>liver failure</keyword>
  <keyword>filter lifespan</keyword>
  <keyword>bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Hepatic Insufficiency</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03791190
org study id: RCA for CRRT in liver failure
nct id: NCT03791190
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this single center, randomized, control, open-labeled study is to evaluate the
      effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure
      and high risk bleeding.
Liver failure (LF) is a common co-morbidity in critical care patients who need continuous
      renal replacement therapy (CRRT). Patients with LF are usually associated with impaired
      coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. KDIGO
      guideline recommended no-anticoagulation for CRRT in patients with liver failure and
      increased bleeding risk. However, the averaged CRRT circuit lifespan under no-coagulation was
      reported to be 7-8 hours in patients with liver failure. Commonly, a CRRT regimen needs more
      than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure
      patients underwent no-anticoagulation CRRT. Several observational studies suggested that
      regional citrate anticoagulation (RCA) during CRRT was effective and safe in patients with
      liver failure. Therefore, the current opinions on the anticoagulation strategy for CRRT in
      patients with liver failure and high bleeding risk are controversial. Therefore, the purpose
      of this single center, randomized, control, open-labeled study is to evaluate the effect and
      safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk
      bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Filter failure
time frame: 72 hours
description: Filter failure
measure: Serum Total Ca2+/ion Ca2+ level
time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
description: Serum Total Ca2+/ ionized Ca2+ level
measure: Hypocalcemia
time frame: 72 hours
description: Ionized Ca2+ < 1.0
measure: Acidosis
time frame: 72 hours
description: Blood pH < 7.35
measure: Alkalosis
time frame: 72 hours.
description: Blood pH > 7.45
measure: Bleeding
time frame: 72 hours
description: Bleeding episode during the CRRT.
measure: Serum citrate concentration
time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours.
description: Citrate concentration
measure: Serum total bilirubin level
time frame: Every 24 hours up to 72 hours.
description: Total bilirubin
measure: Serum AST level
time frame: Every 24 hours up to 72 hours.
description: AST
measure: Serum ALT level
time frame: Every 24 hours up to 72 hours.
description: ALT
arm group label: No-anticoagulation
arm group type: Active Comparator
description: Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution at the speed of 2 L/h.
arm group label: Regional citrate anticoagulation
arm group type: Experimental
description: Patients accepted regional citrate anticoagulation. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+.
Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level.
intervention type: Other
intervention name: Regional citrate anticoagulation
description: Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
arm group label: Regional citrate anticoagulation
other name: RCA
intervention type: Other
intervention name: No-anticoagulation
description: Patients accepted CRRT without anticoagulant.
arm group label: No-anticoagulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shiren Sun, Doctor
role: Study Chair
affiliation: Xijing Hospital, the Fourth Military Medical University
last name: Ming Bai, Doctor
role: Principal Investigator
affiliation: Xijing Hospital, the Fourth Military Medical University
last name: Shiren Sun, Doctor
phone: +8602984775193
email: sunshiren@medmail.com.cn
last name: Ming Bai, Doctor
phone: sunshiren@medmail.com.cn
email: mingbai1983@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Shiren sun
investigator title: Professor
mesh term: Liver Failure
mesh term: Hepatic Insufficiency
mesh term: Hemorrhage