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/NCT05964283</url>
    </required_header>
    <id_info>
      <org_study_id>IndonesiaUAnes047</org_study_id>
      <nct_id>NCT05964283</nct_id>
    </id_info>
    <brief_title>Intravenous Fluid Therapy in Hospitals</brief_title>
    <official_title>Physician Knowledge Level of Intravenous Fluid Therapy in Hospitals: A Cross-Sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia 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 administration of intravenous fluids plays a crucial role in critically ill patients to&#xD;
        support optimal management and ensure patient safety. Knowledge and conceptual frameworks&#xD;
        will influence a clinician's accuracy in providing intravenous fluid therapy to patients.&#xD;
        Accurate administration of fluid therapy to patients will reduce unwanted side effects and&#xD;
        decrease the overall treatment costs during hospitalization. Various considerations in&#xD;
        administering intravenous fluid therapy are influenced by a clinician's level of knowledge.&#xD;
        In Indonesia, doctors working in hospitals may have different levels of education and&#xD;
        professional status. However, it is currently unclear whether these professional differences&#xD;
        among doctors influence their knowledge in administering fluids to patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 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>Questionnaire regarding Physician Knowledge Level of Intravenous fluid therapy</measure>
      <time_frame>one day</time_frame>
      <description>Intravenous Fluid Therapy knowledge Scoring&#xD;
  The principle for scoring these scales is the same in all cases:&#xD;
  Estimate the average of the items that contribute to the scale; this is the raw score. Calculating the raw score=(I1+I2+I3+…+In)/n.&#xD;
  Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (&quot;better&quot;) level of knowledge. Formula use for standardization: Knowledge Score = {1-(Raw score-1)/range} X100&#xD;
  The maximum score is 100 (better outcome) The minimum score is 0 (worse outcome)&#xD;
  All the information related to intravenous fluid therapy is divided into five domains: (1) basic knowledge about electrolyte fluids, (2) intravenous fluid administration, (3) intravenous fluid composition, (4) fluid resuscitation, and (5) assessment of fluid volume status.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Knowledge Level</condition>
    <condition>Intravenous Fluid Therapy</condition>
    <arm_group>
      <arm_group_label>Anesthesia Specialists</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Anesthesiologist residencies</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>This questionnaire consists of (five) main parts. The first part is about personal information, the second part is about fluid administration in various settings (emergency room, operating room, and intensive care unit), the third part is about fluid administration behaviors, the fourth part is about workplace location, and the fifth part is about a case study. Filling out this questionnaire will take approximately 60 minutes of your time.</description>
      <arm_group_label>Anesthesia Specialists</arm_group_label>
      <arm_group_label>Anesthesiologist residencies</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          -  Anesthesia specialists&#xD;
  &#xD;
            -  Anesthesiologist residencies&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All anesthesiologist residencies and are willing to complete the questionnaire.&#xD;
  &#xD;
            -  All anesthesia specialists and subspecialists and are willing to complete the&#xD;
               questionnaire until finished.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  All doctors who are unwilling and do not complete the survey questionnaire.&#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_official>
      <last_name>Dita Aditianingsih</last_name>
      <role>Principal Investigator</role>
      <affiliation>Indonesia University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dita Aditianingsih</last_name>
      <phone>+618151819244</phone>
      <email>ditaaditiaa@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rumah Sakit Cipto Mangunkusumo</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dita Aditianingsih, M.D., Ph.D</last_name>
        <phone>+628151819244</phone>
        <email>ditaaditiaa@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rumah Sakit Cipto Mangunkusumo</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dita Aditianingsih, M.D., Ph.D</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <reference>
      <citation>Malbrain MLNG, Langer T, Annane D, Gattinoni L, Elbers P, Hahn RG, De Laet I, Minini A, Wong A, Ince C, Muckart D, Mythen M, Caironi P, Van Regenmortel N. Intravenous fluid therapy in the perioperative and critical care setting: Executive summary of the International Fluid Academy (IFA). Ann Intensive Care. 2020 May 24;10(1):64. doi: 10.1186/s13613-020-00679-3.</citation>
      <PMID>32449147</PMID>
    </reference>
    <reference>
      <citation>McDougall M, Guthrie B, Doyle A, Timmins A, Bateson M, Ridley E, Drummond G, Vadiveloo T. Introducing NICE guidelines for intravenous fluid therapy into a district general hospital. BMJ Open Qual. 2022 Feb;11(1):e001636. doi: 10.1136/bmjoq-2021-001636.</citation>
      <PMID>35115322</PMID>
    </reference>
    <reference>
      <citation>Finfer S, Myburgh J, Bellomo R. Intravenous fluid therapy in critically ill adults. Nat Rev Nephrol. 2018 Sep;14(9):541-557. doi: 10.1038/s41581-018-0044-0. Erratum In: Nat Rev Nephrol. 2018 Nov;14(11):717.</citation>
      <PMID>30072710</PMID>
    </reference>
    <reference>
      <citation>Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.</citation>
      <PMID>27858374</PMID>
    </reference>
    <reference>
      <citation>Tommasino C. Fluids and the neurosurgical patient. Anesthesiol Clin North Am. 2002 Jun;20(2):329-46, vi. doi: 10.1016/s0889-8537(01)00013-x.</citation>
      <PMID>12165997</PMID>
    </reference>
    <reference>
      <citation>Rudloff E, Hopper K. Crystalloid and Colloid Compositions and Their Impact. Front Vet Sci. 2021 Mar 31;8:639848. doi: 10.3389/fvets.2021.639848. eCollection 2021. Erratum In: Front Vet Sci. 2022 Mar 17;9:878702.</citation>
      <PMID>33869319</PMID>
    </reference>
    <reference>
      <citation>Mackenzie DC, Noble VE. Assessing volume status and fluid responsiveness in the emergency department. Clin Exp Emerg Med. 2014 Dec 31;1(2):67-77. doi: 10.15441/ceem.14.040. eCollection 2014 Dec.</citation>
      <PMID>27752556</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Dita Aditianingsih</investigator_full_name>
      <investigator_title>Principal Investigator, Anesthesiologist Consultant</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/NCT05964283
  org study id: IndonesiaUAnes047
  nct id: NCT05964283
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The administration of intravenous fluids plays a crucial role in critically ill patients to
        support optimal management and ensure patient safety. Knowledge and conceptual frameworks
        will influence a clinician's accuracy in providing intravenous fluid therapy to patients.
        Accurate administration of fluid therapy to patients will reduce unwanted side effects and
        decrease the overall treatment costs during hospitalization. Various considerations in
        administering intravenous fluid therapy are influenced by a clinician's level of knowledge.
        In Indonesia, doctors working in hospitals may have different levels of education and
        professional status. However, it is currently unclear whether these professional differences
        among doctors influence their knowledge in administering fluids to patients.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Questionnaire regarding Physician Knowledge Level of Intravenous fluid therapy
  time frame: one day
  description: Intravenous Fluid Therapy knowledge Scoring
  The principle for scoring these scales is the same in all cases:
  Estimate the average of the items that contribute to the scale; this is the raw score. Calculating the raw score=(I1+I2+I3+…+In)/n.
  Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of knowledge. Formula use for standardization: Knowledge Score = {1-(Raw score-1)/range} X100
  The maximum score is 100 (better outcome) The minimum score is 0 (worse outcome)
  All the information related to intravenous fluid therapy is divided into five domains: (1) basic knowledge about electrolyte fluids, (2) intravenous fluid administration, (3) intravenous fluid composition, (4) fluid resuscitation, and (5) assessment of fluid volume status.
  arm group label: Anesthesia Specialists
  arm group label: Anesthesiologist residencies
  intervention type: Other
  intervention name: Questionnaire
  description: This questionnaire consists of (five) main parts. The first part is about personal information, the second part is about fluid administration in various settings (emergency room, operating room, and intensive care unit), the third part is about fluid administration behaviors, the fourth part is about workplace location, and the fifth part is about a case study. Filling out this questionnaire will take approximately 60 minutes of your time.
  arm group label: Anesthesia Specialists
  arm group label: Anesthesiologist residencies
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dita Aditianingsih
  role: Principal Investigator
  affiliation: Indonesia University
  last name: Dita Aditianingsih
  phone: +618151819244
  email: ditaaditiaa@gmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  citation: Malbrain MLNG, Langer T, Annane D, Gattinoni L, Elbers P, Hahn RG, De Laet I, Minini A, Wong A, Ince C, Muckart D, Mythen M, Caironi P, Van Regenmortel N. Intravenous fluid therapy in the perioperative and critical care setting: Executive summary of the International Fluid Academy (IFA). Ann Intensive Care. 2020 May 24;10(1):64. doi: 10.1186/s13613-020-00679-3.
  PMID: 32449147
  citation: McDougall M, Guthrie B, Doyle A, Timmins A, Bateson M, Ridley E, Drummond G, Vadiveloo T. Introducing NICE guidelines for intravenous fluid therapy into a district general hospital. BMJ Open Qual. 2022 Feb;11(1):e001636. doi: 10.1136/bmjoq-2021-001636.
  PMID: 35115322
  citation: Finfer S, Myburgh J, Bellomo R. Intravenous fluid therapy in critically ill adults. Nat Rev Nephrol. 2018 Sep;14(9):541-557. doi: 10.1038/s41581-018-0044-0. Erratum In: Nat Rev Nephrol. 2018 Nov;14(11):717.
  PMID: 30072710
  citation: Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.
  PMID: 27858374
  citation: Tommasino C. Fluids and the neurosurgical patient. Anesthesiol Clin North Am. 2002 Jun;20(2):329-46, vi. doi: 10.1016/s0889-8537(01)00013-x.
  PMID: 12165997
  citation: Rudloff E, Hopper K. Crystalloid and Colloid Compositions and Their Impact. Front Vet Sci. 2021 Mar 31;8:639848. doi: 10.3389/fvets.2021.639848. eCollection 2021. Erratum In: Front Vet Sci. 2022 Mar 17;9:878702.
  PMID: 33869319
  citation: Mackenzie DC, Noble VE. Assessing volume status and fluid responsiveness in the emergency department. Clin Exp Emerg Med. 2014 Dec 31;1(2):67-77. doi: 10.15441/ceem.14.040. eCollection 2014 Dec.
  PMID: 27752556
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Dita Aditianingsih
  investigator title: Principal Investigator, Anesthesiologist Consultant
  sharing ipd: Undecided