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/NCT06030609</url>
    </required_header>
    <id_info>
      <org_study_id>CUKT-FLUID</org_study_id>
      <nct_id>NCT06030609</nct_id>
    </id_info>
    <brief_title>The Comparison Between Ringer Lactate Solution and Normal Saline in Post-Operative Period of Kidney Transplantation</brief_title>
    <acronym>RINNOR</acronym>
    <official_title>The Comparison Between Ringer Lactate Solution and Normal Saline in the First Week Post-Operative Period of Deceased Donor and Living Donor Kidney Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Chulalongkorn Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King Chulalongkorn Memorial 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>
        This is a randomized controlled pragmatic clinical trial. We aim to evaluate the effect of&#xD;
        Ringer lactate solution (RLS) and normal saline solution (NSS) on the electrolyte abnormality&#xD;
        of kidney transplant recipients (KTR) during the first post-operative week. The problem with&#xD;
        using NSS as a standard replacement fluid is the hyperchloremic metabolic acidosis which&#xD;
        might compromise the kidney allograft function. A total 60 KTR will be enrolled and&#xD;
        randomized to receive either RLS or NSS. The primary outcome is serum bicarbonate level at&#xD;
        day 5 after transplantation. Secondary outcomes include the serum potassium, serum sodium,&#xD;
        serum chloride, cytokine panel, and the incidence of delayed graft function.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2025</primary_completion_date>
    <phase>Phase 3</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>Serum bicarbonate level</measure>
      <time_frame>Day 5 after transplantation</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum potassium level</measure>
      <time_frame>Day 5 after transplantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum chloride level</measure>
      <time_frame>Day 5 after transplantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immune function marker</measure>
      <time_frame>Day 5 after transplantation</time_frame>
      <description>TNF-alpha</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Electrolyte Imbalance</condition>
    <condition>Kidney Transplant; Complications</condition>
    <arm_group>
      <arm_group_label>Ringer lactate arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient will receive RLS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal saline arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patient will receive NSS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ringer's Lactate Crystalloid Solutions</intervention_name>
      <description>The patient will receive RLS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.</description>
      <arm_group_label>Ringer lactate arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal saline</intervention_name>
      <description>The patient will receive NSS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.</description>
      <arm_group_label>Normal saline arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A kidney transplant recipient who receives transplant at King Chulalongkorn Memorial&#xD;
               Hospital.&#xD;
  &#xD;
            -  Age &gt;=18 years&#xD;
  &#xD;
            -  Both deceased donor and living donor kidney transplantation will be included&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  multiorgan transplantation&#xD;
  &#xD;
            -  Known allergy to RLS or NSS&#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_contact>
      <last_name>Suwasin Udomkarnjananun, MD, PhD</last_name>
      <phone>+66899679885</phone>
      <email>suwasin.u@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>King Chulalongkorn Memorial Hospital</investigator_affiliation>
      <investigator_full_name>Suwasin Udomkarnjananun</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06030609
  org study id: CUKT-FLUID
  nct id: NCT06030609
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized controlled pragmatic clinical trial. We aim to evaluate the effect of
        Ringer lactate solution (RLS) and normal saline solution (NSS) on the electrolyte abnormality
        of kidney transplant recipients (KTR) during the first post-operative week. The problem with
        using NSS as a standard replacement fluid is the hyperchloremic metabolic acidosis which
        might compromise the kidney allograft function. A total 60 KTR will be enrolled and
        randomized to receive either RLS or NSS. The primary outcome is serum bicarbonate level at
        day 5 after transplantation. Secondary outcomes include the serum potassium, serum sodium,
        serum chloride, cytokine panel, and the incidence of delayed graft function.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Serum bicarbonate level
  time frame: Day 5 after transplantation
  measure: Serum potassium level
  time frame: Day 5 after transplantation
  measure: Serum chloride level
  time frame: Day 5 after transplantation
  measure: Immune function marker
  time frame: Day 5 after transplantation
  description: TNF-alpha
  arm group label: Ringer lactate arm
  arm group type: Experimental
  description: The patient will receive RLS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
  arm group label: Normal saline arm
  arm group type: Active Comparator
  description: The patient will receive NSS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
  intervention type: Drug
  intervention name: Ringer's Lactate Crystalloid Solutions
  description: The patient will receive RLS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
  arm group label: Ringer lactate arm
  intervention type: Drug
  intervention name: Normal saline
  description: The patient will receive NSS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
  arm group label: Normal saline arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Suwasin Udomkarnjananun, MD, PhD
  phone: +66899679885
  email: suwasin.u@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: King Chulalongkorn Memorial Hospital
  investigator full name: Suwasin Udomkarnjananun
  investigator title: Associate Professor
  sharing ipd: Undecided