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/NCT05962255</url>
    </required_header>
    <id_info>
      <org_study_id>KB-68/2022</org_study_id>
      <nct_id>NCT05962255</nct_id>
    </id_info>
    <brief_title>Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure</brief_title>
    <acronym>SOLVRED-AHF</acronym>
    <official_title>The Impact of Slow, Continuous Infusion of Sodium Chloride or Glucose Solution on Diuresis and Urine Composition During Decongestion of Acute Heart Failure Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wroclaw Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wroclaw Medical University</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>
        The aim of the study is to compare the differences in diuretic, natriuretic and clinical&#xD;
        response to decongestion in patients receiving different replacement fluid regimens (0.9%&#xD;
        sodium chloride vs 5% glucose) in acute heart failure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <intervention_model_description>1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Urine volume change at individual timepoints during first day of the procedure.</measure>
      <time_frame>24 hours</time_frame>
      <description>Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urine volume change at individual timepoints during second day of the procedure.</measure>
      <time_frame>48 hours</time_frame>
      <description>Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urine composition at individual time points.</measure>
      <time_frame>72 hours</time_frame>
      <description>Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cumulative urine output at 24 hours.</measure>
      <time_frame>24 hours</time_frame>
      <description>Comparison of cumulative urine output between the groups at 24 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cumulative urine output at hours.</measure>
      <time_frame>48 hours</time_frame>
      <description>Comparison of cumulative urine output between the groups at 48 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total dose of furosemide.</measure>
      <time_frame>48 hours</time_frame>
      <description>Comparison of the total dose of furosemide between the groups at hours.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total time on intravenous furosemide.</measure>
      <time_frame>3 months</time_frame>
      <description>The total time on intravenous furosemide between hospital admission and discharge will be calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renin-Angiotensin-Aldosterone system activity.</measure>
      <time_frame>24 hours</time_frame>
      <description>Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renin-Angiotensin-Aldosterone system activity.</measure>
      <time_frame>48 hours</time_frame>
      <description>Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Failure rehospitalization</measure>
      <time_frame>30 days</time_frame>
      <description>Compare the need for Heart Failure rehospitalization within 30 days.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Body weight</measure>
      <time_frame>24 hours</time_frame>
      <description>Body weight change after the first day of the procedure.</description>
    </other_outcome>
    <other_outcome>
      <measure>Body weight</measure>
      <time_frame>48 hours</time_frame>
      <description>Body weight change after the second day of the procedure.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Acute Heart Failure</condition>
    <condition>Congestion</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>0.9 % Sodium Chloride solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receiving an intravenous infusion of 0.9% NaCl</description>
    </arm_group>
    <arm_group>
      <arm_group_label>5% Glucose solution</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receiving an intravenous infusion of 5% glucose</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Furosemide intravenous infusion</intervention_name>
      <description>At baseline, patients will receive a standardised dose of furosemide 1mg/kg (half of the dose administered as bolus and half as in 2h infusion).&#xD;
  At the 6th and the 12th hour of the study patients will be reassessed and the need for additional diuretics.</description>
      <arm_group_label>0.9 % Sodium Chloride solution</arm_group_label>
      <arm_group_label>5% Glucose solution</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Continous intravenous infusion of 0.9% Sodium Chloride solution</intervention_name>
      <description>Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h</description>
      <arm_group_label>0.9 % Sodium Chloride solution</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Continous intravenous infusion of 5% Glucose solution</intervention_name>
      <description>Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h</description>
      <arm_group_label>5% Glucose solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients &gt;18 years old who sign the informed consent&#xD;
  &#xD;
            -  the primary cause of hospitalization is Acute Heart Failure with a need for&#xD;
               intravenous Furosemide&#xD;
  &#xD;
            -  the start of the study within 24h of hospital admission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  need for inotropic support&#xD;
  &#xD;
            -  end stage renal disease on dialysis&#xD;
  &#xD;
            -  serum sodium &gt; 148mmol/l or &lt; 130 mmol/l.&#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>Jan Biegus, MD, Ph. D.</last_name>
      <phone>71 736 42 05</phone>
      <phone_ext>+48</phone_ext>
      <email>jan.biegus@umw.edu.pl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gracjan Iwanek, MD</last_name>
      <phone>507046860</phone>
      <phone_ext>+48</phone_ext>
      <email>gracjan.iwanek@student.umw.edu.pl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institute of Heart Diseases, Wroclaw Medical University</name>
        <address>
          <city>Wroclaw</city>
          <state>Lower Silesia</state>
          <zip>50-556</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jan Biegus, MD, Ph. D.</last_name>
        <phone>71 736 42 05</phone>
        <phone_ext>+48</phone_ext>
        <email>jan.biegus@umw.edu.pl</email>
      </contact>
      <contact_backup>
        <last_name>Gracjan Iwanek, MD</last_name>
        <phone>507046860</phone>
        <phone_ext>+48</phone_ext>
        <email>gracjan.iwanek@student.umw.edu.pl</email>
      </contact_backup>
      <investigator>
        <last_name>Gracjan Iwanek, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Szymon Urban, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mateusz Guzik, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert Zymliński, MD, Ph. D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeffrey Testani, MD, MTR</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Piotr Ponikowski, MD, Profesor of Medicine</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jan Biegus, MD, Ph. D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Wroclaw Medical University</investigator_affiliation>
      <investigator_full_name>Gracjan Iwanek</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>acute heart failure</keyword>
    <keyword>decongestion</keyword>
    <keyword>volume replacement</keyword>
    <keyword>sodium chloride</keyword>
    <keyword>congestion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Furosemide</mesh_term>
      <mesh_term>Pharmaceutical Solutions</mesh_term>
    </intervention_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/NCT05962255
  org study id: KB-68/2022
  nct id: NCT05962255
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to compare the differences in diuretic, natriuretic and clinical
        response to decongestion in patients receiving different replacement fluid regimens (0.9%
        sodium chloride vs 5% glucose) in acute heart failure.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Urine volume change at individual timepoints during first day of the procedure.
  time frame: 24 hours
  description: Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.
  measure: Urine volume change at individual timepoints during second day of the procedure.
  time frame: 48 hours
  description: Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.
  measure: Urine composition at individual time points.
  time frame: 72 hours
  description: Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h
  measure: Cumulative urine output at 24 hours.
  time frame: 24 hours
  description: Comparison of cumulative urine output between the groups at 24 hours.
  measure: Cumulative urine output at hours.
  time frame: 48 hours
  description: Comparison of cumulative urine output between the groups at 48 hours.
  measure: Total dose of furosemide.
  time frame: 48 hours
  description: Comparison of the total dose of furosemide between the groups at hours.
  measure: Total time on intravenous furosemide.
  time frame: 3 months
  description: The total time on intravenous furosemide between hospital admission and discharge will be calculated.
  measure: Renin-Angiotensin-Aldosterone system activity.
  time frame: 24 hours
  description: Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.
  measure: Renin-Angiotensin-Aldosterone system activity.
  time frame: 48 hours
  description: Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.
  measure: Heart Failure rehospitalization
  time frame: 30 days
  description: Compare the need for Heart Failure rehospitalization within 30 days.
  measure: Body weight
  time frame: 24 hours
  description: Body weight change after the first day of the procedure.
  measure: Body weight
  time frame: 48 hours
  description: Body weight change after the second day of the procedure.
  arm group label: 0.9 % Sodium Chloride solution
  arm group type: Experimental
  description: Patients receiving an intravenous infusion of 0.9% NaCl
  arm group label: 5% Glucose solution
  arm group type: Active Comparator
  description: Patients receiving an intravenous infusion of 5% glucose
  intervention type: Drug
  intervention name: Furosemide intravenous infusion
  description: At baseline, patients will receive a standardised dose of furosemide 1mg/kg (half of the dose administered as bolus and half as in 2h infusion).
  At the 6th and the 12th hour of the study patients will be reassessed and the need for additional diuretics.
  arm group label: 0.9 % Sodium Chloride solution
  arm group label: 5% Glucose solution
  intervention type: Drug
  intervention name: Continous intravenous infusion of 0.9% Sodium Chloride solution
  description: Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h
  arm group label: 0.9 % Sodium Chloride solution
  intervention type: Drug
  intervention name: Continous intravenous infusion of 5% Glucose solution
  description: Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h
  arm group label: 5% Glucose solution
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jan Biegus, MD, Ph. D.
  phone: 71 736 42 05
  phone ext: +48
  email: jan.biegus@umw.edu.pl
  last name: Gracjan Iwanek, MD
  phone: 507046860
  phone ext: +48
  email: gracjan.iwanek@student.umw.edu.pl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Poland
  responsible party type: Principal Investigator
  investigator affiliation: Wroclaw Medical University
  investigator full name: Gracjan Iwanek
  investigator title: Medical Doctor
  mesh term: Heart Failure
  mesh term: Furosemide
  mesh term: Pharmaceutical Solutions
  sharing ipd: No