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/NCT06034990</url>
    </required_header>
    <id_info>
      <org_study_id>IRB.457/66</org_study_id>
      <nct_id>NCT06034990</nct_id>
    </id_info>
    <brief_title>ICU Fluid Utilization Survey in Southeast Asia</brief_title>
    <acronym>Fluid-SEA</acronym>
    <official_title>ICU Fluid Utilization Survey in Southeast Asia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chulalongkorn University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chulalongkorn 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 objective of this study is to examine the use of different types of fluids for&#xD;
        resuscitation in different phases of fluid management in 3 types of critically ill patients&#xD;
        including (1) not bleeding, not septic but need volume resuscitation (representing normal&#xD;
        condition), (2) bleeding but not septic (representing normal vascular integrity but with a&#xD;
        loss of intravascular colloids), (3) septic (representing the condition with increase&#xD;
        vascular permeability and endothelium damage) in the ICU within Southeast Asia.&#xD;
  &#xD;
        The data are collected by a 10-min online survey administered to included physicians which&#xD;
        will be distributed via multiple online channels through representatives of each countries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this study is to examine the use of different types of fluids for&#xD;
        resuscitation in different phases of fluid management in 3 types of critically ill patients&#xD;
        including (1) not bleeding, not septic but need volume resuscitation (representing normal&#xD;
        condition), (2) bleeding but not septic (representing normal vascular integrity but with a&#xD;
        loss of intravascular colloids), (3) septic (representing the condition with increase&#xD;
        vascular permeability and endothelium damage) in the ICU within Southeast Asia, and to&#xD;
        determine whether co-morbidities with hypoalbuminemia, clinician specialties, hospital&#xD;
        practice settings, geographic locations and re-imbursement limitation especially for colloids&#xD;
        influence the practice patterns of fluid utilization in different phases in the 3 types of&#xD;
        patients. Ultimately, the information provided by this study could also provide basic&#xD;
        background information for the design of future clinical trials regarding fluid resuscitation&#xD;
        strategies.&#xD;
  &#xD;
        The data are collected by a 10-min online survey administered to included physicians which&#xD;
        will be distributed via multiple online channels through representatives of each countries.&#xD;
  &#xD;
        The survey will start with an inform-consent form prior to starting the survey questions&#xD;
        which consist of 13-item questionnaire obtaining information on&#xD;
  &#xD;
          1. Demographics data of clinicians taking the survey on primary specialty, region or&#xD;
             country of practice and hospital settings.&#xD;
  &#xD;
          2. Preferences for volume status indicators.&#xD;
  &#xD;
          3. Preferences for fluid resuscitation in 3 types of patients (1. Septic 2. bleeding but&#xD;
             not septic 3. not bleeding and not septic) during resuscitation and optimization phase.&#xD;
  &#xD;
          4. Preferences for fluid resuscitation in the 3 types of patients with hypoalbuminemia&#xD;
             including (1) cirrhosis (2) nephrotic syndrome (3) other significant hypoalbuminemia&#xD;
             during resuscitation/optimization phase and stabilization phase&#xD;
  &#xD;
          5. The reasons for using colloids for volume expansion&#xD;
  &#xD;
          6. The experience of adverse reactions to albumin&#xD;
  &#xD;
          7. The awareness and importance of non-oncotic properties of albumin&#xD;
  &#xD;
          8. The impact of reimbursement for colloids on resuscitation fluid choice&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Fluid resuscitation practice pattern</measure>
      <time_frame>1/9/23-1/9/24</time_frame>
      <description>Preferences for fluid resuscitation in 3 types of patients (1. Septic 2. bleeding but not septic 3. not bleeding and not septic) during resuscitation and optimization phase.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Preferences for volume status indicators.</measure>
      <time_frame>1/9/23-1/9/24</time_frame>
      <description>Preferences for volume status indicators and diagnostic tools</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fluid resuscitation practice pattern in hypoalbuminemic state</measure>
      <time_frame>1/9/23-1/9/24</time_frame>
      <description>Preferences for fluid resuscitation in the 3 types of patients with hypoalbuminemia including (1) cirrhosis (2) nephrotic syndrome (3) other significant hypoalbuminemia during resuscitation/optimization phase and stabilization phase</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Critical Illness</condition>
    <arm_group>
      <arm_group_label>Survey participants</arm_group_label>
      <description>Participants in this cross-sectional survey will be physicians with specialty in Anesthesiology, Surgery, Critical care medicine, Pulmonology, Nephrology, General Medicine currently working in Surgical or Medical ICU in Southeast Asia in year 2023-2024</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>10-min online survey</intervention_name>
      <description>This is a cross-sectional study. The data are collected by a 10-min online survey administered to included physicians which will be distributed via online channels such as such as official website or Facebook pages of Society of intensive care or Society of nephrology of corresponding countries.</description>
      <arm_group_label>Survey participants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Physicians with specialty in Anesthesiology, Surgery, Critical care medicine, Pulmonology,&#xD;
          Nephrology, General Medicine currently working in Surgical or Medical ICU in Southeast Asia&#xD;
          in year 2023-2024&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          i. Specialty must be in Anesthesiology, Surgery, Critical Care Medicine, Pulmonology,&#xD;
          Nephrology, Internal Medicine, General Practitioner ii. Practice must be in Southeast Asia&#xD;
          hospitals iii. Must work in Surgical ICU, Medical ICU , and/or Mixed ICU&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Physicians who worked in cardiac, neurology or pediatric ICUs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Nattapakorn Mai-on, MD</last_name>
      <phone>+66970051116</phone>
      <email>naphtmaryx@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Miller TE, Bunke M, Nisbet P, Brudney CS. Fluid resuscitation practice patterns in intensive care units of the USA: a cross-sectional survey of critical care physicians. Perioper Med (Lond). 2016 Jun 16;5:15. doi: 10.1186/s13741-016-0035-2. eCollection 2016.</citation>
      <PMID>27313844</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
      <investigator_full_name>Nattachai Srisawat ,M.D.</investigator_full_name>
      <investigator_title>Division of Nephrology</investigator_title>
    </responsible_party>
    <keyword>Crystalloids</keyword>
    <keyword>Colloids</keyword>
    <keyword>Fluid resuscitation</keyword>
    <keyword>Intensive care unit</keyword>
    <keyword>Sepsis</keyword>
    <keyword>Bleeding</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>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/NCT06034990
  org study id: IRB.457/66
  nct id: NCT06034990
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to examine the use of different types of fluids for
        resuscitation in different phases of fluid management in 3 types of critically ill patients
        including (1) not bleeding, not septic but need volume resuscitation (representing normal
        condition), (2) bleeding but not septic (representing normal vascular integrity but with a
        loss of intravascular colloids), (3) septic (representing the condition with increase
        vascular permeability and endothelium damage) in the ICU within Southeast Asia.
  
        The data are collected by a 10-min online survey administered to included physicians which
        will be distributed via multiple online channels through representatives of each countries.
  The objective of this study is to examine the use of different types of fluids for
        resuscitation in different phases of fluid management in 3 types of critically ill patients
        including (1) not bleeding, not septic but need volume resuscitation (representing normal
        condition), (2) bleeding but not septic (representing normal vascular integrity but with a
        loss of intravascular colloids), (3) septic (representing the condition with increase
        vascular permeability and endothelium damage) in the ICU within Southeast Asia, and to
        determine whether co-morbidities with hypoalbuminemia, clinician specialties, hospital
        practice settings, geographic locations and re-imbursement limitation especially for colloids
        influence the practice patterns of fluid utilization in different phases in the 3 types of
        patients. Ultimately, the information provided by this study could also provide basic
        background information for the design of future clinical trials regarding fluid resuscitation
        strategies.
  
        The data are collected by a 10-min online survey administered to included physicians which
        will be distributed via multiple online channels through representatives of each countries.
  
        The survey will start with an inform-consent form prior to starting the survey questions
        which consist of 13-item questionnaire obtaining information on
  
          1. Demographics data of clinicians taking the survey on primary specialty, region or
             country of practice and hospital settings.
  
          2. Preferences for volume status indicators.
  
          3. Preferences for fluid resuscitation in 3 types of patients (1. Septic 2. bleeding but
             not septic 3. not bleeding and not septic) during resuscitation and optimization phase.
  
          4. Preferences for fluid resuscitation in the 3 types of patients with hypoalbuminemia
             including (1) cirrhosis (2) nephrotic syndrome (3) other significant hypoalbuminemia
             during resuscitation/optimization phase and stabilization phase
  
          5. The reasons for using colloids for volume expansion
  
          6. The experience of adverse reactions to albumin
  
          7. The awareness and importance of non-oncotic properties of albumin
  
          8. The impact of reimbursement for colloids on resuscitation fluid choice
  observational model: Other
  time perspective: Cross-Sectional
  measure: Fluid resuscitation practice pattern
  time frame: 1/9/23-1/9/24
  description: Preferences for fluid resuscitation in 3 types of patients (1. Septic 2. bleeding but not septic 3. not bleeding and not septic) during resuscitation and optimization phase.
  measure: Preferences for volume status indicators.
  time frame: 1/9/23-1/9/24
  description: Preferences for volume status indicators and diagnostic tools
  measure: Fluid resuscitation practice pattern in hypoalbuminemic state
  time frame: 1/9/23-1/9/24
  description: Preferences for fluid resuscitation in the 3 types of patients with hypoalbuminemia including (1) cirrhosis (2) nephrotic syndrome (3) other significant hypoalbuminemia during resuscitation/optimization phase and stabilization phase
  arm group label: Survey participants
  description: Participants in this cross-sectional survey will be physicians with specialty in Anesthesiology, Surgery, Critical care medicine, Pulmonology, Nephrology, General Medicine currently working in Surgical or Medical ICU in Southeast Asia in year 2023-2024
  intervention type: Other
  intervention name: 10-min online survey
  description: This is a cross-sectional study. The data are collected by a 10-min online survey administered to included physicians which will be distributed via online channels such as such as official website or Facebook pages of Society of intensive care or Society of nephrology of corresponding countries.
  arm group label: Survey participants
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  last name: Nattapakorn Mai-on, MD
  phone: +66970051116
  email: naphtmaryx@gmail.com
  citation: Miller TE, Bunke M, Nisbet P, Brudney CS. Fluid resuscitation practice patterns in intensive care units of the USA: a cross-sectional survey of critical care physicians. Perioper Med (Lond). 2016 Jun 16;5:15. doi: 10.1186/s13741-016-0035-2. eCollection 2016.
  PMID: 27313844
  responsible party type: Principal Investigator
  investigator affiliation: Chulalongkorn University
  investigator full name: Nattachai Srisawat ,M.D.
  investigator title: Division of Nephrology
  mesh term: Critical Illness
  sharing ipd: No