<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/NCT03799133</url>
  </required_header>
  <id_info>
    <org_study_id>ISM_VC_01_17</org_study_id>
    <secondary_id>17-1025</secondary_id>
    <nct_id>NCT03799133</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery</brief_title>
  <official_title>Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Critical Perfusion Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Nacional de Cardiologia Ignacio Chavez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gerbera Capital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alandra Medical SAPI de CV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Critical Perfusion Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical&#xD;
      Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients&#xD;
      post-operated of elective cardiovascular surgery.&#xD;
&#xD;
      Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality&#xD;
      (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk&#xD;
      predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective&#xD;
      cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric&#xD;
      reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective&#xD;
      cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing&#xD;
      cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A maximum of 35 patients with age greater or equal to 18 years with elective surgery&#xD;
      (valvular surgery, revascularization, or a combination of both) that comply with the&#xD;
      inclusion/exclusion criteria of this protocol will be enrolled.&#xD;
&#xD;
      Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative&#xD;
      with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed&#xD;
      venous saturation.&#xD;
&#xD;
      The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in&#xD;
      ICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2018</start_date>
  <completion_date type="Actual">December 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Eligible patients will be placed the Florence catheter.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between gastric reactance (XL) and morbimortality and risk predictors</measure>
    <time_frame>72 hours</time_frame>
    <description>Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensibility and specificity of the collected variables</measure>
    <time_frame>72 hours</time_frame>
    <description>ROC curves will be calculated to determine sensibility and specificity of the variables.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events tracing with the use of Florence catheter</measure>
    <time_frame>30 days</time_frame>
    <description>Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlations between XL measurements and medication</measure>
    <time_frame>72 hours</time_frame>
    <description>Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with amines, proton-pump inhibitors, and anesthesia medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations between laboratory parameters and XL</measure>
    <time_frame>72 hours</time_frame>
    <description>Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability of Florence device in a real environment.</measure>
    <time_frame>72 hours</time_frame>
    <description>Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cardiac Failure</condition>
  <condition>Ventricular Dysfunction</condition>
  <condition>Valvular Heart Disease</condition>
  <arm_group>
    <arm_group_label>Patients with Florence device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Florence device</intervention_name>
    <description>The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.</description>
    <arm_group_label>Patients with Florence device</arm_group_label>
    <other_name>ISMO</other_name>
    <other_name>Gastric Impedance Spectrometer System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and men within an age equal or greater than 18 years old.&#xD;
&#xD;
          -  Subjects scheduled to an elective cardiac surgery for valvular surgery,&#xD;
             revascularization or a combination of both.&#xD;
&#xD;
          -  Subjects compliant with the indication to be placed a floating pulmonary artery&#xD;
             catheter.&#xD;
&#xD;
          -  Marks results previous to surgery: STS mortality risk equal or greater than 6% of the&#xD;
             day before or Euro Score II with a mortality risk equal or greater than 6% or left&#xD;
             ventricle ejection fraction (LVEF/FEVI) less than 45% (patients with cardiac failure&#xD;
             or right ventricle dysfunction or a combination of both), tricuspid annular plane&#xD;
             systolic excursion (TAPSE) less than 17 mm, peak systolic velocity of tricuspid&#xD;
             lateral ring measured by Tissue Doppler (LVOT/TSVI) less than 0.1 m/s; patient with&#xD;
             elective surgery of: aortic and mitral valve replacement or aortic and mitral valve&#xD;
             replacement + tricuspid valve plasty or aortic valve replacement + mitral valve plasty&#xD;
             or mitral valve replacement + tricuspid valve plasty or aortic, mitral and tricuspid&#xD;
             valve replacement or aortic valve replacement + tricuspid valve plasty or double valve&#xD;
             replacement (any combination) + revascularization or aortic valve replacement +&#xD;
             revascularization + mitral valve plasty.&#xD;
&#xD;
          -  Subject is not enrolled in another investigational protocol.&#xD;
&#xD;
          -  Informed consent has been signed of acceptance by the subject before study procedures.&#xD;
&#xD;
          -  Subject in sinus rhythm before surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with records of recent digestive tube bleeding (last 30 days).&#xD;
&#xD;
          -  Paraplegic or hemiplegic subjects.&#xD;
&#xD;
          -  Subjects with congenital background (interauricular communication, ventricular atrial&#xD;
             channel, coarctation of the aorta, persistent arterial duct, pulmonary stenosis,&#xD;
             ventricular septal defect, tetralogy of fallot, total or partial anomalous pulmonary&#xD;
             venous drainage, transposition of the great vessels, tricuspid atresia, arterial&#xD;
             trunk, etc).&#xD;
&#xD;
          -  Maxillofacial malformation.&#xD;
&#xD;
          -  Catheter placement failure.&#xD;
&#xD;
          -  Known pregnancy or discovered pregnancy after admission (before surgery).&#xD;
&#xD;
          -  Woman in breastfeeding period.&#xD;
&#xD;
          -  Subjects not compliant with clinical indication of nasogastric catheter placement or&#xD;
             contraindicated to place a nasogastric catheter.&#xD;
&#xD;
          -  Subjects with an implanted pacemaker or permanent defibrillator.&#xD;
&#xD;
          -  Medication supply that impedes contact between Florence catheter and the gastric&#xD;
             mucosa (barrier effect) like sucralfate, aluminum hydroxide, bismuth subsalicylate,&#xD;
             magaldrate, etc.&#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>Rolando J. Álvarez Álvarez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Cardiologia Ignacio Chavez</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Montserrat Godínez, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Alandra Medical SAPI de CV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Cardiología Ignacio Chávez</name>
      <address>
        <city>Tlalpan</city>
        <state>Ciudad De México</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
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    <url>http://www.who.int/mediacentre/factsheets/fs317/es/</url>
    <description>WHO Cardiovascular illness; 2015</description>
  </link>
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    <url>http://www.medigraphic.com/pdfs/cardio/h-2016/hs163a.pdf</url>
    <description>Arias AS, Serrano MEB, Altamirano BD, Ortega MG, Gonzalez GG. Cardiovascular illness: first cause of morbility in a third level hospital. Cardiology Mexican Journal; 2016</description>
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  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/8087584</url>
    <description>Chalfin DB, Fein AM. Critical care medicine in managed competition and a managed care environment. New horizons (Baltimore, Md). 1994 Aug;2:275-282</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/19559823</url>
    <description>O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2-isolated valve surgery. The Annals of thoracic surgery. 2009 Jul;88:S23-S42</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/19559822</url>
    <description>Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1-coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S2-22</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/19559824</url>
    <description>Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3-valve plus coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S43-S62</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/23522221</url>
    <description>Rankin JS, He X, O'Brien SM, Jacobs JP, Welke KF, Filardo G, et al. The Society of Thoracic Surgeons risk model for operative mortality after multiple valve surgery. The Annals of thoracic surgery. 2013 Apr;95:1484-1490</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric reactance</keyword>
  <keyword>elective cardiac surgery</keyword>
  <keyword>morbimortality</keyword>
  <keyword>APACHE II</keyword>
  <keyword>STS</keyword>
  <keyword>SOFA</keyword>
  <keyword>EUROSCORE II</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03799133
org study id: ISM_VC_01_17
secondary id: 17-1025
nct id: NCT03799133
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical
      Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients
      post-operated of elective cardiovascular surgery.

      Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality
      (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk
      predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective
      cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric
      reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective
      cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing
      cardiac surgery.
A maximum of 35 patients with age greater or equal to 18 years with elective surgery
      (valvular surgery, revascularization, or a combination of both) that comply with the
      inclusion/exclusion criteria of this protocol will be enrolled.

      Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative
      with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed
      venous saturation.

      The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in
      ICU.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Eligible patients will be placed the Florence catheter.
primary purpose: Screening
masking: None (Open Label)
measure: Correlation between gastric reactance (XL) and morbimortality and risk predictors
time frame: 72 hours
description: Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL).
measure: Sensibility and specificity of the collected variables
time frame: 72 hours
description: ROC curves will be calculated to determine sensibility and specificity of the variables.
measure: Adverse events tracing with the use of Florence catheter
time frame: 30 days
description: Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.
measure: Correlations between XL measurements and medication
time frame: 72 hours
description: Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with amines, proton-pump inhibitors, and anesthesia medications.
measure: Correlations between laboratory parameters and XL
time frame: 72 hours
description: Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters.
measure: Usability of Florence device in a real environment.
time frame: 72 hours
description: Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.
arm group label: Patients with Florence device
arm group type: Experimental
description: Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.
intervention type: Device
intervention name: Florence device
description: The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
arm group label: Patients with Florence device
other name: ISMO
other name: Gastric Impedance Spectrometer System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rolando J. Álvarez Álvarez, MD
role: Principal Investigator
affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
last name: Montserrat Godínez, MSc
role: Study Director
affiliation: Alandra Medical SAPI de CV
facility: 
country: Mexico
url: http://www.who.int/mediacentre/factsheets/fs317/es/
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url: https://www.ncbi.nlm.nih.gov/pubmed/6851607
description: NIH. Consensus Development Conference on critical care medicine. Critical care medicine. 1983 Jun;11:466-469
url: https://www.ncbi.nlm.nih.gov/pubmed/8087584
description: Chalfin DB, Fein AM. Critical care medicine in managed competition and a managed care environment. New horizons (Baltimore, Md). 1994 Aug;2:275-282
url: https://www.ncbi.nlm.nih.gov/pubmed/19559823
description: O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2-isolated valve surgery. The Annals of thoracic surgery. 2009 Jul;88:S23-S42
url: https://www.ncbi.nlm.nih.gov/pubmed/19559822
description: Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1-coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S2-22
url: https://www.ncbi.nlm.nih.gov/pubmed/19559824
description: Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3-valve plus coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S43-S62
url: https://www.ncbi.nlm.nih.gov/pubmed/23522221
description: Rankin JS, He X, O'Brien SM, Jacobs JP, Welke KF, Filardo G, et al. The Society of Thoracic Surgeons risk model for operative mortality after multiple valve surgery. The Annals of thoracic surgery. 2013 Apr;95:1484-1490
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Ventricular Dysfunction
mesh term: Heart Valve Diseases
mesh term: Heart Failure
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers.