<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/NCT04506021</url>
  </required_header>
  <id_info>
    <org_study_id>TJH-MCTBR</org_study_id>
    <nct_id>NCT04506021</nct_id>
  </id_info>
  <brief_title>A Real World Study on Clinical Efficacy of Bicarbonate Ringer's Solution in Biliary Atresia Children</brief_title>
  <official_title>A Multicenter Real World Study on Clinical Efficacy of Sodium Bicarbonate Ringer's Solution in Children With Biliary Atresia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</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>
      In most babies with biliary atresia (BA) bile ducts on the inside and outside of the liver&#xD;
      are affected eventually leading to a complete blockage of bile flow from the liver. This in&#xD;
      turn causes scarring (fibrosis) in the liver. The surgery called the Kasai procedure and&#xD;
      eventually, a liver transplant could treat biliary atresia. However, children with BA have&#xD;
      poor liver function, poor renal reserve, and poor ability to regulate water and electrolytes.&#xD;
      Therefore, A reasonable and effective perioperative fluid management is more significant.&#xD;
      Considering the high chlorine of saline, the liver burden of Lactated Ringer's solution and&#xD;
      Acetated Ringer's solution, the Bicarbonate Ringer's solution which composition is similar to&#xD;
      plasma, could be the best choice for perioperative fluid management of BA children.&#xD;
      Therefore, we hypothesize that compared with other crystalloids, Bicarbonate Ringer's&#xD;
      solution is a better choice to maintain water, electrolyte and acid-base balance in BA&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>Arterial blood gas changes</measure>
    <time_frame>1 day</time_frame>
    <description>Compared with the baseline, the patient's base excess and pH changes at the operation 1h, operation 2h, and the end of the operation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraoperative dosage of sodium bicarbonate injection</measure>
    <time_frame>1 day</time_frame>
    <description>Patients with acidosis during the operation needs to be corrected with sodium bicarbonate injection. We collect the amount of sodium bicarbonate injection used to correct metabolic acidosis during the operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chlorine concentration</measure>
    <time_frame>3 days</time_frame>
    <description>We collected the concentration of chloride ion in the patient's blood and urine during the baseline, the operation and three days after operation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Biliary Atresia</condition>
  <arm_group>
    <arm_group_label>Bicarbonate Ringer's Solution</arm_group_label>
    <description>According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution.&#xD;
drug dosage form: Solution, Intravenous infusion. the drug dosage frequency and duration were no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other Crystalloid</arm_group_label>
    <description>According to the choices of patients' immediate family members, patients will be divided into Other Crystalloid.&#xD;
drug dosage form: Solution, Intravenous infusion. the drug dosage frequency and duration were no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bicarbonate Ringer's solution</intervention_name>
    <description>According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention.</description>
    <arm_group_label>Bicarbonate Ringer's Solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other Crystalloid</intervention_name>
    <description>According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.</description>
    <arm_group_label>Other Crystalloid</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study Population was diagnosed with biliary atresia, who need Intravenous infusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients diagnosed with biliary atresia before surgery.&#xD;
&#xD;
          2. age less than 90 days.&#xD;
&#xD;
          3. American Society of Anesthesiologists score of 1~2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with severe allergies.&#xD;
&#xD;
          2. patients with severe deformities or lesions.&#xD;
&#xD;
          3. other situations not suitable for enrollment judged by researchers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>90 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiexiong Feng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji hospital of huazhong university of science and technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiexiong Feng, prof.</last_name>
    <phone>18607187276</phone>
    <phone_ext>86-</phone_ext>
    <email>wangpeipeggy@126.com</email>
  </overall_contact>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>J.X. Feng</investigator_full_name>
    <investigator_title>prof.</investigator_title>
  </responsible_party>
  <keyword>Biliary Atresia</keyword>
  <keyword>Bicarbonate Ringer's solution</keyword>
  <keyword>Perioperative fluid management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Atresia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 7, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04506021
org study id: TJH-MCTBR
nct id: NCT04506021
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In most babies with biliary atresia (BA) bile ducts on the inside and outside of the liver
      are affected eventually leading to a complete blockage of bile flow from the liver. This in
      turn causes scarring (fibrosis) in the liver. The surgery called the Kasai procedure and
      eventually, a liver transplant could treat biliary atresia. However, children with BA have
      poor liver function, poor renal reserve, and poor ability to regulate water and electrolytes.
      Therefore, A reasonable and effective perioperative fluid management is more significant.
      Considering the high chlorine of saline, the liver burden of Lactated Ringer's solution and
      Acetated Ringer's solution, the Bicarbonate Ringer's solution which composition is similar to
      plasma, could be the best choice for perioperative fluid management of BA children.
      Therefore, we hypothesize that compared with other crystalloids, Bicarbonate Ringer's
      solution is a better choice to maintain water, electrolyte and acid-base balance in BA
      children.
observational model: Cohort
time perspective: Prospective
measure: Arterial blood gas changes
time frame: 1 day
description: Compared with the baseline, the patient's base excess and pH changes at the operation 1h, operation 2h, and the end of the operation.
measure: Intraoperative dosage of sodium bicarbonate injection
time frame: 1 day
description: Patients with acidosis during the operation needs to be corrected with sodium bicarbonate injection. We collect the amount of sodium bicarbonate injection used to correct metabolic acidosis during the operation
measure: Chlorine concentration
time frame: 3 days
description: We collected the concentration of chloride ion in the patient's blood and urine during the baseline, the operation and three days after operation
arm group label: Bicarbonate Ringer's Solution
description: According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution.
drug dosage form: Solution, Intravenous infusion. the drug dosage frequency and duration were no intervention
arm group label: Other Crystalloid
description: According to the choices of patients' immediate family members, patients will be divided into Other Crystalloid.
drug dosage form: Solution, Intravenous infusion. the drug dosage frequency and duration were no intervention
intervention type: Drug
intervention name: Bicarbonate Ringer's solution
description: According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention.
arm group label: Bicarbonate Ringer's Solution
intervention type: Drug
intervention name: Other Crystalloid
description: According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.
arm group label: Other Crystalloid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 90 Days
healthy volunteers: No
last name: Jiexiong Feng
role: Principal Investigator
affiliation: Tongji hospital of huazhong university of science and technology
last name: Jiexiong Feng, prof.
phone: 18607187276
phone ext: 86-
email: wangpeipeggy@126.com
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: J.X. Feng
investigator title: prof.
mesh term: Biliary Atresia
submitted: August 7, 2023