<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/NCT03237429</url>
  </required_header>
  <id_info>
    <org_study_id>GTPopaUMP</org_study_id>
    <nct_id>NCT03237429</nct_id>
  </id_info>
  <brief_title>The Relationship Between BCM, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia</brief_title>
  <official_title>The Relationship Between Volemic Status as Assessed by Bioimpedance Spectroscopy, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grigore T. Popa University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grigore T. Popa University of Medicine and Pharmacy</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>
      Arterial hypotension during induction of general anesthesia is a risk factor for developing&#xD;
      postoperative cardiovascular complications. After induction of general anesthesia patients&#xD;
      have a high risk of developing arterial hypotension due to anesthetic drugs who can depress&#xD;
      cardiac contractility and determine vasodilatation. Previous studies have shown that even&#xD;
      short periods of hypotension with a mean arterial pressure of less than 55 mmHg during&#xD;
      surgery is associated with an increased incidence of cardiac injury and acute kidney injury&#xD;
      in the postoperative period.&#xD;
&#xD;
      The volemic status of the patients in the preoperative period is very difficult to quantify&#xD;
      and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting.&#xD;
      Bioimpedance is recognized by over 30 years as a simple and non invasive technique to&#xD;
      determine the volemic status especially in the hemodialysed patients. A new device BCM- Body&#xD;
      Composition Monitoring (Fresenius Medical Care) offers a simple method to determine&#xD;
      extracellular water and total body water. These volumes are determined by measuring impedance&#xD;
      at 50 different frequencies thru electrodes placed at the ankle and wrist. BCM can also&#xD;
      determine lean tissue mass and adipose tissue mass.&#xD;
&#xD;
      Increasing arterial stiffness is the main characteristic of arterial aging; this increase&#xD;
      determines the increase of the afterload, left ventricular hypertrophy, the decrease of&#xD;
      coronary and tissue perfusion. Arterial applanation tonometry is a non-invasive technique&#xD;
      that has been shown to reliably provide indices of arterial stiffness.&#xD;
&#xD;
      In this study investigators wish to determine if there is a correlation between the hidric&#xD;
      status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor&#xD;
      system and the development of hypotension during induction of general anesthesia. The&#xD;
      measurements will be obtained before induction of general anesthesia in the pre-surgical&#xD;
      area. During induction of general anesthesia with standard induction agents and Bispectral&#xD;
      index monitoring, brachial blood pressure will be measured by a cuff every minute after the&#xD;
      loss of verbal contact with the patient up to ten minutes after tracheal intubation. A&#xD;
      hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below&#xD;
      55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the&#xD;
      patient before the surgery.&#xD;
&#xD;
      Measurement of the hidric status and aortic stiffness may represent a valid indicator of the&#xD;
      risk of hypotension during anesthesia induction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arterial hypotension during induction of general anesthesia is a risk factor for developing&#xD;
      postoperative cardiovascular complications. After induction of general anesthesia patients&#xD;
      have a high risk of developing arterial hypotension due to anesthetic drugs who can depress&#xD;
      cardiac contractility and determine vasodilatation. Risk factors associated with increased&#xD;
      incidence of arterial hypotension at induction of general anesthesia are age &gt; 50 years, ASA&#xD;
      risk class III or IV, using high doses of propofol or fetanyl at induction. Previous studies&#xD;
      have shown that even short periods of hypotension with a mean arterial pressure of less than&#xD;
      55 mmHg during surgery is associated with an increased incidence of cardiac injury and acute&#xD;
      kidney injury in the postoperative period. Even if it is known that arterial hypotension is&#xD;
      associated with increased incidence of postoperative complications, the inferior limit and&#xD;
      duration of hypotension is not well defined. The volemic status of the patients in the&#xD;
      preoperative period is very difficult to quantify and can vary due to comorbidities of the&#xD;
      patient, chronic treatment, preoperative fasting. Bioimpedance is recognized by over 30 years&#xD;
      as a simple and non invasive technique to determine the volemic status especially in the&#xD;
      hemodialyzed patients. A new device BCM- Body Composition Monitoring (Fresenius Medical Care)&#xD;
      offers a simple method to determine extracellular water and total body water. These volumes&#xD;
      are determined by measuring impedance at 50 different frequencies thrue electrodes placed at&#xD;
      the ankle and wrist. BCM can also determine lean tissue mass and adipose tissue mass.&#xD;
&#xD;
      Increasing arterial stiffness is the main characteristic of arterial aging; this increase&#xD;
      determines the increase of the afterload, left ventricular hypertrophy, the decrease of&#xD;
      coronary and tissue perfusion. Increased arterial stiffness is associated with altered&#xD;
      ability of maintaining a normal arterial pressure during stress conditions; it is known the&#xD;
      risk of orthostatic hypotension in older patients wits increased arterial stiffness Arterial&#xD;
      applanation tonometry is asimple, non-invasive technique that has been shown to reliably&#xD;
      provide indices of arterial stiffness. Measuring carotid-femural pulse wave velocity thrue&#xD;
      applanation tonometry is considered the &quot;gold standard&quot; for measuring arterial stiffness.In&#xD;
      this study carotid-femoral pulse wave velocity will be determined by applanation tonometry&#xD;
      using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery&#xD;
      waveforms. Pulse wave signals will be recorded by tonometers positioned at the base of the&#xD;
      right common carotid artery and over the right femoral artery.&#xD;
&#xD;
      In this study investigators wish to determine if there is a correlation between the hidric&#xD;
      status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor&#xD;
      system and the development of hypotension during induction of general anesthesia. The&#xD;
      measurements will be obtained before induction of general anesthesia in the pre-surgical&#xD;
      area. During induction of general anesthesia with standard induction agents(fentanyl&#xD;
      propofol, rocuronium) and Bispectral index monitoring, brachial blood pressure will be&#xD;
      measured by a cuff every minute after the loss of verbal contact with the patient up to ten&#xD;
      minutes after tracheal intubation. A hypotensive response to anesthesia will be defined as a&#xD;
      drop in mean arterial pressure below 55mmHg or a drop in mean arterial pressure with more&#xD;
      than 40% than the base line value of the patient before the surgery.&#xD;
&#xD;
      Study population : patients who are going under surgery. Inclusion criteria: there will be&#xD;
      two study populations. The first study population will represent patients scheduled for&#xD;
      surgery for a new diagnosed cancer pathology. The second study population will represent&#xD;
      patients scheduled for surgery not for cancer disease. Exclusion criteria: diabetes (on&#xD;
      insulin therapy), renal insufficiency (creatinine&gt;2.0mg/dl), history of arterial bypass),&#xD;
      history of carotid endoarterectomy, atrial fibrillation/flutter, history of ischemic stroke,&#xD;
      transient ischemic attack, myocardial infarction or coronary revascularization (any type)&#xD;
      within 6 months, known left main or 3-vessel coronary disease positive myocardial perfusion&#xD;
      study without subsequent revascularization, heart failure (&gt;3 NYHA) class 3, known left&#xD;
      ventricle ejection fraction &lt;30%, pulmonary hypertension (PA systolic &gt;50mmHg), right&#xD;
      ventricle dysfunction, sepsis, pregnancy, limb amputation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</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>Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between arterial stiffness and hypotension during induction of general anesthesia</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation between the carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Vascular Stiffness</condition>
  <condition>Hypotension on Induction</condition>
  <condition>Anesthesia; Reaction</condition>
  <arm_group>
    <arm_group_label>cancer patients</arm_group_label>
    <description>The first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-cancer patients</arm_group_label>
    <description>The second study population will represent patients scheduled for surgery not for cancer disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>bioimpedance spectroscopy</intervention_name>
    <description>Bioimpedance spectroscopy-The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid.&#xD;
Carotid-femoral pulse wave velocity-will be determined by arterial applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms.. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery.</description>
    <arm_group_label>cancer patients</arm_group_label>
    <arm_group_label>non-cancer patients</arm_group_label>
    <other_name>Carotid-femoral pulse wave velocity</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients scheduled for surgery for a new diagnosed cancer pathology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients scheduled for surgery for a new diagnosed cancer pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes (on insulin therapy),&#xD;
&#xD;
          -  renal insufficiency (creatinine&gt;2.0mg/dl),&#xD;
&#xD;
          -  history of arterial bypass, carotid endoarterectomy,&#xD;
&#xD;
          -  history of atrial fibrillation/flutter, ischemic stroke, transient ischemic attack,&#xD;
             myocardial infarction or coronary revascularization (any type) within 6 months,&#xD;
&#xD;
          -  known left main or 3-vessel coronary disease positive myocardial perfusion study&#xD;
             without subsequent revascularization,&#xD;
&#xD;
          -  heart failure (&gt;3 NYHA) class 3, known left ventricle ejection fraction &lt;30%,&#xD;
             pulmonary hypertension (PA systolic &gt;50mmHg), right ventricle dysfunction,&#xD;
&#xD;
          -  sepsis,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  limb amputation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitrie Siriopol, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>GRT POPA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ianis Siriopol</last_name>
    <phone>+40746215967</phone>
    <email>ianis.siriopol@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Regional Institute of Oncology, Iasi</name>
      <address>
        <city>Iași</city>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ianis Siriopol</last_name>
      <phone>+o746215967</phone>
      <email>ianis.siriopol@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grigore T. Popa University of Medicine and Pharmacy</investigator_affiliation>
    <investigator_full_name>Professor Adrian Covic</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>bioimpedance spectroscopy</keyword>
  <keyword>arterial stiffness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03237429
org study id: GTPopaUMP
nct id: NCT03237429
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Arterial hypotension during induction of general anesthesia is a risk factor for developing
      postoperative cardiovascular complications. After induction of general anesthesia patients
      have a high risk of developing arterial hypotension due to anesthetic drugs who can depress
      cardiac contractility and determine vasodilatation. Previous studies have shown that even
      short periods of hypotension with a mean arterial pressure of less than 55 mmHg during
      surgery is associated with an increased incidence of cardiac injury and acute kidney injury
      in the postoperative period.

      The volemic status of the patients in the preoperative period is very difficult to quantify
      and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting.
      Bioimpedance is recognized by over 30 years as a simple and non invasive technique to
      determine the volemic status especially in the hemodialysed patients. A new device BCM- Body
      Composition Monitoring (Fresenius Medical Care) offers a simple method to determine
      extracellular water and total body water. These volumes are determined by measuring impedance
      at 50 different frequencies thru electrodes placed at the ankle and wrist. BCM can also
      determine lean tissue mass and adipose tissue mass.

      Increasing arterial stiffness is the main characteristic of arterial aging; this increase
      determines the increase of the afterload, left ventricular hypertrophy, the decrease of
      coronary and tissue perfusion. Arterial applanation tonometry is a non-invasive technique
      that has been shown to reliably provide indices of arterial stiffness.

      In this study investigators wish to determine if there is a correlation between the hidric
      status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor
      system and the development of hypotension during induction of general anesthesia. The
      measurements will be obtained before induction of general anesthesia in the pre-surgical
      area. During induction of general anesthesia with standard induction agents and Bispectral
      index monitoring, brachial blood pressure will be measured by a cuff every minute after the
      loss of verbal contact with the patient up to ten minutes after tracheal intubation. A
      hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below
      55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the
      patient before the surgery.

      Measurement of the hidric status and aortic stiffness may represent a valid indicator of the
      risk of hypotension during anesthesia induction.
Arterial hypotension during induction of general anesthesia is a risk factor for developing
      postoperative cardiovascular complications. After induction of general anesthesia patients
      have a high risk of developing arterial hypotension due to anesthetic drugs who can depress
      cardiac contractility and determine vasodilatation. Risk factors associated with increased
      incidence of arterial hypotension at induction of general anesthesia are age > 50 years, ASA
      risk class III or IV, using high doses of propofol or fetanyl at induction. Previous studies
      have shown that even short periods of hypotension with a mean arterial pressure of less than
      55 mmHg during surgery is associated with an increased incidence of cardiac injury and acute
      kidney injury in the postoperative period. Even if it is known that arterial hypotension is
      associated with increased incidence of postoperative complications, the inferior limit and
      duration of hypotension is not well defined. The volemic status of the patients in the
      preoperative period is very difficult to quantify and can vary due to comorbidities of the
      patient, chronic treatment, preoperative fasting. Bioimpedance is recognized by over 30 years
      as a simple and non invasive technique to determine the volemic status especially in the
      hemodialyzed patients. A new device BCM- Body Composition Monitoring (Fresenius Medical Care)
      offers a simple method to determine extracellular water and total body water. These volumes
      are determined by measuring impedance at 50 different frequencies thrue electrodes placed at
      the ankle and wrist. BCM can also determine lean tissue mass and adipose tissue mass.

      Increasing arterial stiffness is the main characteristic of arterial aging; this increase
      determines the increase of the afterload, left ventricular hypertrophy, the decrease of
      coronary and tissue perfusion. Increased arterial stiffness is associated with altered
      ability of maintaining a normal arterial pressure during stress conditions; it is known the
      risk of orthostatic hypotension in older patients wits increased arterial stiffness Arterial
      applanation tonometry is asimple, non-invasive technique that has been shown to reliably
      provide indices of arterial stiffness. Measuring carotid-femural pulse wave velocity thrue
      applanation tonometry is considered the "gold standard" for measuring arterial stiffness.In
      this study carotid-femoral pulse wave velocity will be determined by applanation tonometry
      using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery
      waveforms. Pulse wave signals will be recorded by tonometers positioned at the base of the
      right common carotid artery and over the right femoral artery.

      In this study investigators wish to determine if there is a correlation between the hidric
      status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor
      system and the development of hypotension during induction of general anesthesia. The
      measurements will be obtained before induction of general anesthesia in the pre-surgical
      area. During induction of general anesthesia with standard induction agents(fentanyl
      propofol, rocuronium) and Bispectral index monitoring, brachial blood pressure will be
      measured by a cuff every minute after the loss of verbal contact with the patient up to ten
      minutes after tracheal intubation. A hypotensive response to anesthesia will be defined as a
      drop in mean arterial pressure below 55mmHg or a drop in mean arterial pressure with more
      than 40% than the base line value of the patient before the surgery.

      Study population : patients who are going under surgery. Inclusion criteria: there will be
      two study populations. The first study population will represent patients scheduled for
      surgery for a new diagnosed cancer pathology. The second study population will represent
      patients scheduled for surgery not for cancer disease. Exclusion criteria: diabetes (on
      insulin therapy), renal insufficiency (creatinine>2.0mg/dl), history of arterial bypass),
      history of carotid endoarterectomy, atrial fibrillation/flutter, history of ischemic stroke,
      transient ischemic attack, myocardial infarction or coronary revascularization (any type)
      within 6 months, known left main or 3-vessel coronary disease positive myocardial perfusion
      study without subsequent revascularization, heart failure (>3 NYHA) class 3, known left
      ventricle ejection fraction <30%, pulmonary hypertension (PA systolic >50mmHg), right
      ventricle dysfunction, sepsis, pregnancy, limb amputation.
observational model: Cohort
time perspective: Prospective
measure: Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia
time frame: 2 years
description: Correlation between the hydric status determined by BCM and the development of hypotension during induction of general anesthesia
measure: Correlation between arterial stiffness and hypotension during induction of general anesthesia
time frame: 2 years
description: Correlation between the carotid-femural pulse wave velocity determined with SphygmoCor system and the development of hypotension during induction of general anesthesia
arm group label: cancer patients
description: The first study population will represent patients scheduled for surgery for a new diagnosed cancer pathology
arm group label: non-cancer patients
description: The second study population will represent patients scheduled for surgery not for cancer disease
intervention type: Diagnostic Test
intervention name: bioimpedance spectroscopy
description: Bioimpedance spectroscopy-The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid.
Carotid-femoral pulse wave velocity-will be determined by arterial applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms.. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery.
arm group label: cancer patients
arm group label: non-cancer patients
other name: Carotid-femoral pulse wave velocity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dimitrie Siriopol, MD, PhD
role: Study Chair
affiliation: GRT POPA
last name: Ianis Siriopol
phone: +40746215967
email: ianis.siriopol@gmail.com
facility: 
status: Recruiting
contact: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Grigore T. Popa University of Medicine and Pharmacy
investigator full name: Professor Adrian Covic
investigator title: Professor
mesh term: Hypotension