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/NCT05975086</url>
    </required_header>
    <id_info>
      <org_study_id>RVD</org_study_id>
      <nct_id>NCT05975086</nct_id>
    </id_info>
    <brief_title>Right Ventricle Dysfunction in Critically Ill Patients</brief_title>
    <official_title>Right Ventricle Dysfunction in Critically Ill Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To assess prevalence of right ventricle dysfunction in critically ill patient. To assess&#xD;
        impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and&#xD;
        long term outcome (&gt;30 days).&#xD;
  &#xD;
        To assess the accuracy of different parameters of RV dysfunction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Inclusion criteria:&#xD;
  &#xD;
             - Adult patients who admitted to critical care of Internal medicine department after&#xD;
             obtaining consent during the period between august 2023 and august 2024.&#xD;
  &#xD;
          2. Exclusion criteria:&#xD;
  &#xD;
               1. Children below 18 yr.&#xD;
  &#xD;
               2. Patients who could not be scanned within 48h after ICU admission.&#xD;
  &#xD;
          3. Sample Size Calculation:&#xD;
  &#xD;
             200 patients 2.4.4 Study tools (in detail, e.g., lab methods, instruments, steps,&#xD;
             chemicals, ):&#xD;
  &#xD;
             Beside history and clinical examination , The following data will be obtained:&#xD;
  &#xD;
             Demographic and historical data: the patient age, sex, history of hypertension, chronic&#xD;
             obstructive pulmonary disease, IHD, cause of critical care unit admission and indication&#xD;
             of mechanical ventilation( PEEP).&#xD;
  &#xD;
             Clinical examination data: pulse, blood pressure, respiratory rate, temperature , BMI,&#xD;
             and thorough chest, cardiac examination data will be obtained.&#xD;
  &#xD;
             Volume state of the patient: CVP measurement, input and output fluid chart. APACHE IV&#xD;
             score, Use of vasopressors, Use of sedatives. Investigation : Arterial blood gas&#xD;
             analysis, pulse oxygen saturation, CBC, and renal function test and electrolytes, serum&#xD;
             lactate and troponin.&#xD;
  &#xD;
             12 lead ECG for RV strain patterns.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome</measure>
      <time_frame>Baseline</time_frame>
      <description>To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (&gt;30 days).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome</measure>
      <time_frame>Baseline</time_frame>
      <description>To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (&gt;30 days).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Right Ventricular Dysfunction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          - Adult patients who admitted to critical care of Internal medicine department after&#xD;
          obtaining consent during the period between august 2023 and august 2024.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients who admitted to critical care of Internal medicine department after&#xD;
               obtaining consent during the period between august 2023 and august 2024.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Children below 18 yr.&#xD;
  &#xD;
            2. Patients who could not be scanned within 48h after ICU admission.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Mustafa Shaban Abdelsalam</last_name>
      <phone>01020216526</phone>
      <email>mustafashaban039@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammed Hossam Maghraby</last_name>
      <phone>01006261166</phone>
      <email>hossammaghraby@med.aun.edu.eg</email>
    </overall_contact_backup>
    <reference>
      <citation>Vieillard-Baron A, Millington SJ, Sanfilippo F, Chew M, Diaz-Gomez J, McLean A, Pinsky MR, Pulido J, Mayo P, Fletcher N. A decade of progress in critical care echocardiography: a narrative review. Intensive Care Med. 2019 Jun;45(6):770-788. doi: 10.1007/s00134-019-05604-2. Epub 2019 Mar 25. Erratum In: Intensive Care Med. 2019 Apr 15;:</citation>
      <PMID>30911808</PMID>
    </reference>
    <reference>
      <citation>Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.</citation>
      <PMID>29744563</PMID>
    </reference>
    <reference>
      <citation>Vieillard-Baron A, Pinsky MR. The difficulty in defining right ventricular failure at the bedside and its clinical significance. Ann Intensive Care. 2021 Aug 5;11(1):122. doi: 10.1186/s13613-021-00912-7. No abstract available.</citation>
      <PMID>34351534</PMID>
    </reference>
    <reference>
      <citation>Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.</citation>
      <PMID>20620859</PMID>
    </reference>
    <reference>
      <citation>Vos ME, Cox EGM, Schagen MR, Hiemstra B, Wong A, Koeze J, van der Horst ICC, Wiersema R; SICS Study Group. Right ventricular strain measurements in critically ill patients: an observational SICS sub-study. Ann Intensive Care. 2022 Oct 3;12(1):92. doi: 10.1186/s13613-022-01064-y.</citation>
      <PMID>36190597</PMID>
    </reference>
    <reference>
      <citation>Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Erratum In: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969.</citation>
      <PMID>25712077</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mustafa Shaban Abdelsalam Thabet</investigator_full_name>
      <investigator_title>Resident doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ventricular Dysfunction</mesh_term>
      <mesh_term>Ventricular Dysfunction, Right</mesh_term>
    </condition_browse>
    <!-- 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/NCT05975086
  org study id: RVD
  nct id: NCT05975086
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess prevalence of right ventricle dysfunction in critically ill patient. To assess
        impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and
        long term outcome (>30 days).
  
        To assess the accuracy of different parameters of RV dysfunction.
  1. Inclusion criteria:
  
             - Adult patients who admitted to critical care of Internal medicine department after
             obtaining consent during the period between august 2023 and august 2024.
  
          2. Exclusion criteria:
  
               1. Children below 18 yr.
  
               2. Patients who could not be scanned within 48h after ICU admission.
  
          3. Sample Size Calculation:
  
             200 patients 2.4.4 Study tools (in detail, e.g., lab methods, instruments, steps,
             chemicals, ):
  
             Beside history and clinical examination , The following data will be obtained:
  
             Demographic and historical data: the patient age, sex, history of hypertension, chronic
             obstructive pulmonary disease, IHD, cause of critical care unit admission and indication
             of mechanical ventilation( PEEP).
  
             Clinical examination data: pulse, blood pressure, respiratory rate, temperature , BMI,
             and thorough chest, cardiac examination data will be obtained.
  
             Volume state of the patient: CVP measurement, input and output fluid chart. APACHE IV
             score, Use of vasopressors, Use of sedatives. Investigation : Arterial blood gas
             analysis, pulse oxygen saturation, CBC, and renal function test and electrolytes, serum
             lactate and troponin.
  
             12 lead ECG for RV strain patterns.
  observational model: Cohort
  time perspective: Prospective
  measure: Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome
  time frame: Baseline
  description: To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (>30 days).
  measure: Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome
  time frame: Baseline
  description: To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (>30 days).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  last name: Mustafa Shaban Abdelsalam
  phone: 01020216526
  email: mustafashaban039@gmail.com
  last name: Mohammed Hossam Maghraby
  phone: 01006261166
  email: hossammaghraby@med.aun.edu.eg
  citation: Vieillard-Baron A, Millington SJ, Sanfilippo F, Chew M, Diaz-Gomez J, McLean A, Pinsky MR, Pulido J, Mayo P, Fletcher N. A decade of progress in critical care echocardiography: a narrative review. Intensive Care Med. 2019 Jun;45(6):770-788. doi: 10.1007/s00134-019-05604-2. Epub 2019 Mar 25. Erratum In: Intensive Care Med. 2019 Apr 15;:
  PMID: 30911808
  citation: Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.
  PMID: 29744563
  citation: Vieillard-Baron A, Pinsky MR. The difficulty in defining right ventricular failure at the bedside and its clinical significance. Ann Intensive Care. 2021 Aug 5;11(1):122. doi: 10.1186/s13613-021-00912-7. No abstract available.
  PMID: 34351534
  citation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
  PMID: 20620859
  citation: Vos ME, Cox EGM, Schagen MR, Hiemstra B, Wong A, Koeze J, van der Horst ICC, Wiersema R; SICS Study Group. Right ventricular strain measurements in critically ill patients: an observational SICS sub-study. Ann Intensive Care. 2022 Oct 3;12(1):92. doi: 10.1186/s13613-022-01064-y.
  PMID: 36190597
  citation: Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Erratum In: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969.
  PMID: 25712077
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mustafa Shaban Abdelsalam Thabet
  investigator title: Resident doctor
  mesh term: Ventricular Dysfunction
  mesh term: Ventricular Dysfunction, Right