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/NCT05968066</url>
    </required_header>
    <id_info>
      <org_study_id>PRoFLUID</org_study_id>
      <nct_id>NCT05968066</nct_id>
    </id_info>
    <brief_title>Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients</brief_title>
    <acronym>PRoFLUID</acronym>
    <official_title>Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mahidol Oxford Tropical Medicine Research Unit</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Amsterdam UMC, location VUmc</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital, Antwerp</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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 goal of this woldwide observational study is to investigate various aspects of fluid and&#xD;
        vasopressor therapy in critically ill invasively ventilated patients. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  What is the global current practice of fluid and vasopressor therapy?&#xD;
  &#xD;
          -  What are associations between this practice and clinical outcomes?&#xD;
  &#xD;
        Participating intensive care units will gather detailed information about fluid and&#xD;
        vasopressor therapy prescribed to participants. Participating intensive care units will also&#xD;
        gather information about participant outcomes such as duration of invasive ventilation,&#xD;
        length of stay and mortality&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale:&#xD;
  &#xD;
        The worldwide practice of fluid and vasopressor therapy in critically ill invasively&#xD;
        ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in&#xD;
        fluid and vasopressor therapy in these patients between Low- and Middle-income Countries&#xD;
        (LMICs) and High-income Countries (HICs).&#xD;
  &#xD;
        Objective:&#xD;
  &#xD;
        To determine various aspects of fluid and vasopressor therapy in critically ill invasively&#xD;
        ventilated patients in LMICs and HICs.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        There is substantial worldwide variation in practice of fluid and vasopressor therapy in&#xD;
        critically ill invasively ventilated patients.&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        International, multicenter, observational study in critically ill invasively ventilated&#xD;
        patients; data are captured during a predefined period per geographic region or country.&#xD;
  &#xD;
        Study population:&#xD;
  &#xD;
        Critically ill invasively ventilated patients.&#xD;
  &#xD;
        Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
        relatedness:&#xD;
  &#xD;
        Because of the observational design of the study using routinely collected data, there is no&#xD;
        additional burden for the patient. Collection of data from ICU charts or electronic medical&#xD;
        records systems is of no risk to the patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>Composite of various aspects of fluid therapy</measure>
      <time_frame>seven days</time_frame>
      <description>Including total volumes of types of fluids administered in the first three days after ICU admission and total volume of fluids infused in the first seven days of ICU admission</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timing of start of continuous administration of vasopressors.</measure>
      <time_frame>seven days</time_frame>
      <description>Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of vasopressor therapy</measure>
      <time_frame>seven days</time_frame>
      <description>In days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Types of vasopressors</measure>
      <time_frame>seven days</time_frame>
      <description>The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of types of vasopressors</measure>
      <time_frame>seven days</time_frame>
      <description>The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timing of start of administered diuretics.</measure>
      <time_frame>seven days</time_frame>
      <description>Time between start of invasive ventilation and administration of diuretics in days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of diuretic therapy</measure>
      <time_frame>seven days</time_frame>
      <description>In days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Types of diuretics</measure>
      <time_frame>seven days</time_frame>
      <description>The type of diuretics that are prescribed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bolus or continous infusion of diuretics</measure>
      <time_frame>seven days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative fluid balances</measure>
      <time_frame>seven days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily urine output</measure>
      <time_frame>seven days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of atrial arrythmias</measure>
      <time_frame>7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of acute respiratory distress syndrome</measure>
      <time_frame>7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of renal replacement therapy</measure>
      <time_frame>7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of need for renal replacement therapy at ICU discharge.</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Pre-defined subgroup analysis in patients admitted with burns</measure>
      <time_frame>90 days</time_frame>
      <description>All aforementioned outcomes in patients with burns</description>
    </other_outcome>
    <other_outcome>
      <measure>Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome</measure>
      <time_frame>90 days</time_frame>
      <description>All aforementioned outcomes in patients with acute respiratory distress syndrome</description>
    </other_outcome>
    <other_outcome>
      <measure>Pre-defined subgroup analysis in patients admitted with sepsis</measure>
      <time_frame>90 days</time_frame>
      <description>All aforementioned outcomes in patients with sepsis</description>
    </other_outcome>
    <enrollment type="Anticipated">2500</enrollment>
    <condition>Fluid Therapy</condition>
    <condition>Vasopressor Therapy</condition>
    <condition>Critical Illness</condition>
    <condition>Invasive Ventilation</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Critically ill invasively ventilated patients that receive ventilation for at least 24&#xD;
          hours.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admitted to a participating intensive care unit;&#xD;
  &#xD;
            -  Receiving invasive ventilation; and&#xD;
  &#xD;
            -  Duration of ventilation &gt; 24 hours.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 16 years;&#xD;
  &#xD;
            -  Patients transferred under invasive ventilation from another intensive care unit.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Pieter R. Tuinman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Amsterdam UMC, location VUmc</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Frederique Paulus, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Amsterdam UMC, location AMC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Marcus J. Schultz, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mahidol Oxford Tropical Medicine Research Unit</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Siebe G. Blok, MD</last_name>
      <phone>020 566 9111</phone>
      <email>siebeblok@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Prof. Dr. Marcus J. Schultz</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>Fluid Therapy</keyword>
    <keyword>Vasopressor</keyword>
    <keyword>Resuscitation</keyword>
    <keyword>Deresuscitation</keyword>
    <keyword>Fluids</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <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/NCT05968066
  org study id: PRoFLUID
  nct id: NCT05968066
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this woldwide observational study is to investigate various aspects of fluid and
        vasopressor therapy in critically ill invasively ventilated patients. The main questions it
        aims to answer are:
  
          -  What is the global current practice of fluid and vasopressor therapy?
  
          -  What are associations between this practice and clinical outcomes?
  
        Participating intensive care units will gather detailed information about fluid and
        vasopressor therapy prescribed to participants. Participating intensive care units will also
        gather information about participant outcomes such as duration of invasive ventilation,
        length of stay and mortality
  Rationale:
  
        The worldwide practice of fluid and vasopressor therapy in critically ill invasively
        ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in
        fluid and vasopressor therapy in these patients between Low- and Middle-income Countries
        (LMICs) and High-income Countries (HICs).
  
        Objective:
  
        To determine various aspects of fluid and vasopressor therapy in critically ill invasively
        ventilated patients in LMICs and HICs.
  
        Hypothesis:
  
        There is substantial worldwide variation in practice of fluid and vasopressor therapy in
        critically ill invasively ventilated patients.
  
        Study design:
  
        International, multicenter, observational study in critically ill invasively ventilated
        patients; data are captured during a predefined period per geographic region or country.
  
        Study population:
  
        Critically ill invasively ventilated patients.
  
        Nature and extent of the burden and risks associated with participation, benefit and group
        relatedness:
  
        Because of the observational design of the study using routinely collected data, there is no
        additional burden for the patient. Collection of data from ICU charts or electronic medical
        records systems is of no risk to the patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Composite of various aspects of fluid therapy
  time frame: seven days
  description: Including total volumes of types of fluids administered in the first three days after ICU admission and total volume of fluids infused in the first seven days of ICU admission
  measure: Timing of start of continuous administration of vasopressors.
  time frame: seven days
  description: Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)
  measure: Duration of vasopressor therapy
  time frame: seven days
  description: In days
  measure: Types of vasopressors
  time frame: seven days
  description: The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed
  measure: Concentration of types of vasopressors
  time frame: seven days
  description: The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route
  measure: Timing of start of administered diuretics.
  time frame: seven days
  description: Time between start of invasive ventilation and administration of diuretics in days
  measure: Duration of diuretic therapy
  time frame: seven days
  description: In days
  measure: Types of diuretics
  time frame: seven days
  description: The type of diuretics that are prescribed
  measure: Bolus or continous infusion of diuretics
  time frame: seven days
  measure: Cumulative fluid balances
  time frame: seven days
  measure: Daily urine output
  time frame: seven days
  measure: Incidence of atrial arrythmias
  time frame: 7 days
  measure: Incidence of acute respiratory distress syndrome
  time frame: 7 days
  measure: Incidence of renal replacement therapy
  time frame: 7 days
  measure: Incidence of need for renal replacement therapy at ICU discharge.
  time frame: 90 days
  measure: Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital
  time frame: 90 days
  measure: Pre-defined subgroup analysis in patients admitted with burns
  time frame: 90 days
  description: All aforementioned outcomes in patients with burns
  measure: Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome
  time frame: 90 days
  description: All aforementioned outcomes in patients with acute respiratory distress syndrome
  measure: Pre-defined subgroup analysis in patients admitted with sepsis
  time frame: 90 days
  description: All aforementioned outcomes in patients with sepsis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  last name: Pieter R. Tuinman, MD
  role: Principal Investigator
  affiliation: Amsterdam UMC, location VUmc
  last name: Frederique Paulus, Professor
  role: Principal Investigator
  affiliation: Amsterdam UMC, location AMC
  last name: Marcus J. Schultz, Professor
  role: Principal Investigator
  affiliation: Mahidol Oxford Tropical Medicine Research Unit
  last name: Siebe G. Blok, MD
  phone: 020 566 9111
  email: siebeblok@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Prof. Dr. Marcus J. Schultz
  investigator title: Prof. Dr.
  mesh term: Critical Illness
  sharing ipd: Undecided