<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/NCT03228329</url>
  </required_header>
  <id_info>
    <org_study_id>N-43-2017</org_study_id>
    <nct_id>NCT03228329</nct_id>
  </id_info>
  <brief_title>Validation of Cardiometry in Resuscitation of Patients Undergoing Liver Transplantation</brief_title>
  <official_title>Validation of Electrical Cardiometry in Resuscitation of Patients Undergoing Orthotopic Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</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>
      aim of our study to validate electrical cardiometry readings against same readings by&#xD;
      transoesophageal echo. we will validate stroke volume (SV) readings stroke volume&#xD;
      variation(SVV), index of contractility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Induction of anaesthesia will be by using propofol (2mg.kg) IV, fentanyl (1-2μg. kg) IV and&#xD;
      atracurium (0.5 mg.kg) IV. Anaesthesia will be maintained with Sevoflurane adjusted between&#xD;
      1-2% in an air ⁄ oxygen mix (FiO2 0.6), fentanyl infusion at 1-2 μg.kg/h and atracurium&#xD;
      infusion at 0.5 mg.kg/ h. Mechanical ventilation will be provided by using a Dräger&#xD;
      anaesthesia machine (Dräger Primus®, Germany) using a tidal volume of 6-8 ml.kg with the&#xD;
      respiratory rate adjusted to maintain the PaCO2 between 4-4.6 kilopascal (kPa) and positive&#xD;
      end expiratory pressure (PEEP) of 5 cmH2O. All patients will be monitored for five lead ECG,&#xD;
      peripheral oxygen saturation, noninvasive and invasive arterial blood pressure, temperature,&#xD;
      end-tidal carbon dioxide tension, hourly urinary output, and central venous pressure (CVP). A&#xD;
      7-Fr triple lumen CVP catheter (Arrow International Inc, Reading, PA, USA) will be inserted&#xD;
      into the right internal jugular vein.&#xD;
&#xD;
      All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative&#xD;
      fluid. If SVV is more than 15%, the patient will be considered as fluid responder and will&#xD;
      receive a 250-ml bolus of albumin 5% to maintain SVV ≤15%. Blood transfusion will be given&#xD;
      based on a hemoglobin level (&lt; 7 g/dl). Norepinephrine will be administered if the mean&#xD;
      arterial pressure was less than 70 mmHg. Epinephrine will be administered if mean arterial&#xD;
      blood pressure was less than 70 mm Hg and the cardiac index was less than 2.5 L/min/m2&#xD;
      despite sufficient volume infusion, to maintain a target cardiac index of 2.5-3.0 L/min/m2&#xD;
&#xD;
      Electrical cardiometry (EC) Examination:&#xD;
&#xD;
        1. ECG electrodes will be placed on the bare skin of patients in the following positions:&#xD;
&#xD;
             1. On the left neck below the ear;&#xD;
&#xD;
             2. Directly above the midpoint of the left clavicle;&#xD;
&#xD;
             3. Along the left mid-axillary line at the level of the xiphoid process;&#xD;
&#xD;
             4. Two inches caudal from the third electrode.&#xD;
&#xD;
        2. Patient characteristics of sex, age, height and weight will be entered into the monitor.&#xD;
&#xD;
        3. Clocks on the EC and trans esophageal echo (TEE) machine will be synchronized prior to&#xD;
           data collection.&#xD;
&#xD;
        4. The EC monitor will be programmed to capture moving averages of variables based on the&#xD;
           previous 10 cardiac cycles and to record those averages every10 s.&#xD;
&#xD;
        5. Only EC data with a signal quality index (SQI) of &gt;70 will be included in the analysis.&#xD;
&#xD;
      Echo Examination:&#xD;
&#xD;
        1. A single LVOT diameter will be measured for each patient as the distance between the&#xD;
           inﬂection points at the base of the aortic valve cusps from the left ventricle long axis&#xD;
           view during systole.&#xD;
&#xD;
        2. Assuming a circular cross section, the LVOT area will be calculated from the LVOT&#xD;
           diameter as:&#xD;
&#xD;
           π X (LVOT diameter/ 2)2 = (LVOT diameter)2 X 0.785&#xD;
&#xD;
        3. Pulse wave Doppler sampling cursor will be placed in the middle of the LVOT immediately&#xD;
           proximal to the aortic valve in 5 chamber deep transgastric view.&#xD;
&#xD;
        4. The sonographer manually will trace the velocity-time envelope.&#xD;
&#xD;
        5. SV values will be identified for 10 cycles and averaged to obtain SV-Doppler max and&#xD;
           SV-Doppler min. The mean SV (SV-Doppler mean) will be calculated as (SV-Doppler max -&#xD;
           SV-Doppler min)/2.&#xD;
&#xD;
        6. SVV-Doppler will be calculated as (SV-Doppler max - SV-Doppler min)/SV-Doppler mean.&#xD;
&#xD;
        7. Peak aortic velocity, time to peak and mean acceleration will be calculated.&#xD;
&#xD;
      Mini Fluid challenge:&#xD;
&#xD;
        1. Mini fluid challenge will be done by 150 cc crystalloid over 1 min&#xD;
&#xD;
        2. 2 sets of measurement of SV and SVV will be obtained&#xD;
&#xD;
             1. The first set of measurement will be obtained before fluid challenge.&#xD;
&#xD;
             2. The second set will be obtained immediately after fluid challenge. Other data will&#xD;
                be recorded as;heart rate (HR), systolic BP, Diastolic BP, mean BP, CVP and pulse&#xD;
                pressure variation (PPV)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stroke volume</measure>
    <time_frame>5 minutes after reperfusion.</time_frame>
    <description>record stroke volume assessed by noninvasive cardiometry and TEE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stroke volume</measure>
    <time_frame>15 minutes after dissection phase.</time_frame>
    <description>record stroke volume assessed by noninvasive cardiometry and TEE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>5 minutes after reperfusion.</time_frame>
    <description>record stroke volume assessed by noninvasive cardiometry and TEE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>15 minutes after dissection phase</time_frame>
    <description>record stroke volume variation assessed by noninvasive cardiometry and TEE</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Liver Transplantation</condition>
  <arm_group>
    <arm_group_label>cardiometry</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fluid boluses</intervention_name>
    <description>fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations</description>
    <arm_group_label>cardiometry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA II to IV patients with end-stage liver disease&#xD;
&#xD;
          -  patients undergoing orthotopic living donor liver transplantation&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute fulminant liver failure&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ahmed mohamed mokhtar, M.D</last_name>
    <role>Study Director</role>
    <affiliation>kasralainy faculty of medicine, Cairo university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy Hospital , Faculty of Medicine</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.</citation>
    <PMID>10840602</PMID>
  </reference>
  <reference>
    <citation>Rossi G, Langer M, Maggi U, Reggiani P, Caccamo L, Gatti S, Paone G, Vannelli A, Prato P, Doglia M, Melada E, Latham L, Fassati LR. Veno-venous bypass versus no bypass in orthotopic liver transplantation: hemodynamic, metabolic, and renal data. Transplant Proc. 1998 Aug;30(5):1871-3. doi: 10.1016/s0041-1345(98)00465-5. No abstract available.</citation>
    <PMID>9723316</PMID>
  </reference>
  <reference>
    <citation>Bulkley GB. Reactive oxygen metabolites and reperfusion injury: aberrant triggering of reticuloendothelial function. Lancet. 1994 Oct 1;344(8927):934-6. doi: 10.1016/s0140-6736(94)92276-4. No abstract available.</citation>
    <PMID>7848422</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Mohamed Elayashy Mohamed Ahmed Hassan</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <keyword>cardiometry</keyword>
  <keyword>stroke volume</keyword>
  <keyword>liver transplantation</keyword>
  <!-- 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/NCT03228329
org study id: N-43-2017
nct id: NCT03228329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
aim of our study to validate electrical cardiometry readings against same readings by
      transoesophageal echo. we will validate stroke volume (SV) readings stroke volume
      variation(SVV), index of contractility.
Induction of anaesthesia will be by using propofol (2mg.kg) IV, fentanyl (1-2μg. kg) IV and
      atracurium (0.5 mg.kg) IV. Anaesthesia will be maintained with Sevoflurane adjusted between
      1-2% in an air ⁄ oxygen mix (FiO2 0.6), fentanyl infusion at 1-2 μg.kg/h and atracurium
      infusion at 0.5 mg.kg/ h. Mechanical ventilation will be provided by using a Dräger
      anaesthesia machine (Dräger Primus®, Germany) using a tidal volume of 6-8 ml.kg with the
      respiratory rate adjusted to maintain the PaCO2 between 4-4.6 kilopascal (kPa) and positive
      end expiratory pressure (PEEP) of 5 cmH2O. All patients will be monitored for five lead ECG,
      peripheral oxygen saturation, noninvasive and invasive arterial blood pressure, temperature,
      end-tidal carbon dioxide tension, hourly urinary output, and central venous pressure (CVP). A
      7-Fr triple lumen CVP catheter (Arrow International Inc, Reading, PA, USA) will be inserted
      into the right internal jugular vein.

      All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative
      fluid. If SVV is more than 15%, the patient will be considered as fluid responder and will
      receive a 250-ml bolus of albumin 5% to maintain SVV ≤15%. Blood transfusion will be given
      based on a hemoglobin level (< 7 g/dl). Norepinephrine will be administered if the mean
      arterial pressure was less than 70 mmHg. Epinephrine will be administered if mean arterial
      blood pressure was less than 70 mm Hg and the cardiac index was less than 2.5 L/min/m2
      despite sufficient volume infusion, to maintain a target cardiac index of 2.5-3.0 L/min/m2

      Electrical cardiometry (EC) Examination:

        1. ECG electrodes will be placed on the bare skin of patients in the following positions:

             1. On the left neck below the ear;

             2. Directly above the midpoint of the left clavicle;

             3. Along the left mid-axillary line at the level of the xiphoid process;

             4. Two inches caudal from the third electrode.

        2. Patient characteristics of sex, age, height and weight will be entered into the monitor.

        3. Clocks on the EC and trans esophageal echo (TEE) machine will be synchronized prior to
           data collection.

        4. The EC monitor will be programmed to capture moving averages of variables based on the
           previous 10 cardiac cycles and to record those averages every10 s.

        5. Only EC data with a signal quality index (SQI) of >70 will be included in the analysis.

      Echo Examination:

        1. A single LVOT diameter will be measured for each patient as the distance between the
           inﬂection points at the base of the aortic valve cusps from the left ventricle long axis
           view during systole.

        2. Assuming a circular cross section, the LVOT area will be calculated from the LVOT
           diameter as:

           π X (LVOT diameter/ 2)2 = (LVOT diameter)2 X 0.785

        3. Pulse wave Doppler sampling cursor will be placed in the middle of the LVOT immediately
           proximal to the aortic valve in 5 chamber deep transgastric view.

        4. The sonographer manually will trace the velocity-time envelope.

        5. SV values will be identified for 10 cycles and averaged to obtain SV-Doppler max and
           SV-Doppler min. The mean SV (SV-Doppler mean) will be calculated as (SV-Doppler max -
           SV-Doppler min)/2.

        6. SVV-Doppler will be calculated as (SV-Doppler max - SV-Doppler min)/SV-Doppler mean.

        7. Peak aortic velocity, time to peak and mean acceleration will be calculated.

      Mini Fluid challenge:

        1. Mini fluid challenge will be done by 150 cc crystalloid over 1 min

        2. 2 sets of measurement of SV and SVV will be obtained

             1. The first set of measurement will be obtained before fluid challenge.

             2. The second set will be obtained immediately after fluid challenge. Other data will
                be recorded as;heart rate (HR), systolic BP, Diastolic BP, mean BP, CVP and pulse
                pressure variation (PPV)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: stroke volume
time frame: 5 minutes after reperfusion.
description: record stroke volume assessed by noninvasive cardiometry and TEE
measure: stroke volume
time frame: 15 minutes after dissection phase.
description: record stroke volume assessed by noninvasive cardiometry and TEE
measure: stroke volume variation
time frame: 5 minutes after reperfusion.
description: record stroke volume assessed by noninvasive cardiometry and TEE
measure: stroke volume variation
time frame: 15 minutes after dissection phase
description: record stroke volume variation assessed by noninvasive cardiometry and TEE
arm group label: cardiometry
arm group type: Other
description: fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations
intervention type: Other
intervention name: fluid boluses
description: fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations
arm group label: cardiometry
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: ahmed mohamed mokhtar, M.D
role: Study Director
affiliation: kasralainy faculty of medicine, Cairo university
facility: 
country: Egypt
citation: Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
PMID: 10840602
citation: Rossi G, Langer M, Maggi U, Reggiani P, Caccamo L, Gatti S, Paone G, Vannelli A, Prato P, Doglia M, Melada E, Latham L, Fassati LR. Veno-venous bypass versus no bypass in orthotopic liver transplantation: hemodynamic, metabolic, and renal data. Transplant Proc. 1998 Aug;30(5):1871-3. doi: 10.1016/s0041-1345(98)00465-5. No abstract available.
PMID: 9723316
citation: Bulkley GB. Reactive oxygen metabolites and reperfusion injury: aberrant triggering of reticuloendothelial function. Lancet. 1994 Oct 1;344(8927):934-6. doi: 10.1016/s0140-6736(94)92276-4. No abstract available.
PMID: 7848422
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Mohamed Elayashy Mohamed Ahmed Hassan
investigator title: clinical professor