<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/NCT03038165</url>
  </required_header>
  <id_info>
    <org_study_id>GMC170114CTIL</org_study_id>
    <nct_id>NCT03038165</nct_id>
  </id_info>
  <brief_title>Hemodynamic Parameters Changes in the Course of Hemodialysis Sessions in Patients With Intradialytic Hypertension</brief_title>
  <official_title>Hemodynamic Parameters Changes in the Course of Hemodialysis Sessions in Patients With Intradialytic Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</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>
      While the exact pathogenesis of Intradialytic hypertension remains to be determined, several&#xD;
      mechanisms were proposed to be involved. The main factors to determine the arterial blood&#xD;
      pressure are the peripheral vascular resistance and cardiac output. The assumption is that&#xD;
      the increase of blood pressure is related to the increase in peripheral vascular resistance&#xD;
      during the dialysis session, due to fluid removal and fast reduction of the intravascular&#xD;
      volume reduction.&#xD;
&#xD;
      Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients&#xD;
      with intradialytic hypertension will be evaluated&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of patients with end stage renal disease (ESRD) is growing worldwide and nowadays&#xD;
      hemodialysis (HD) treatment is the prevalent modality of renal replacement therapy.&#xD;
      Paradoxically an increase of BP during or immediately after the HD sessions has been observed&#xD;
      in some patients. This phenomenon is referred to as Intradialytic Hypertension (IDH). The&#xD;
      focus will be on systolic BP increase ≥ 10 mmHg during or immediately after hemodialysis&#xD;
      which results in post-dialysis hypertension BP above ≥130/80 mmHg. IDH affects up to 10-15%&#xD;
      of hemodialysis patients. Patients with IDH have unfavorable outcomes; previous&#xD;
      epidemiological data showed that IDH is associated with higher cardiovascular morbidity and&#xD;
      mortality rates.&#xD;
&#xD;
      From the view of hemodynamic profile, peripheral resistance and cardiac output are the most&#xD;
      important factors contributing to arterial blood pressure. The pathogenesis of IDH is likely&#xD;
      to be multifactorial. Several mechanisms were proposed to be involved in the pathogenesis of&#xD;
      this phenomenon.&#xD;
&#xD;
      Endothelial dysfunction, increased activity of the renin angiotensin aldosterone system&#xD;
      (RAAS) and activation of the sympathetic nervous system had been shown to be involved in the&#xD;
      increase of blood pressure during Hemodialysis in this group of patients.&#xD;
&#xD;
      None of these possible explanations or their inter-relationships has been studied in a&#xD;
      controlled experimental setting and the actual physiological changes during hemodialysis in&#xD;
      intradialytic hypertensive patients still remain unexplored.&#xD;
&#xD;
      The NICAS (Non-Invasive Cardiac System) device, used mainly for noninvasive cardiac&#xD;
      diagnostic purposes, is substantially equivalent to the use of other hemodynamic evaluation&#xD;
      tools, yet it is non-invasive and provides on-line data regarding the hemodynamic status of&#xD;
      patients. Using this device, the hemodynamic changes during the HD session of IDH patients&#xD;
      will be investigated.&#xD;
&#xD;
      By using the NICAS device, the hemodynamics parameters changes during the dialysis session&#xD;
      will be measured. The parameters that will be measured are heart rate, stroke volume, cardiac&#xD;
      index, cardiac power index and total peripheral vascular resistance.&#xD;
&#xD;
      During the hemodialysis treatment several hemodynamic changes may occur due to intravascular&#xD;
      volume reduction. Changes in peripheral vascular resistance, cardiac output and cardiac power&#xD;
      index contribute to the hemodynamic stability during the dialysis session.&#xD;
&#xD;
      By using a non-invasive technique, the NICAS device,hemodynamic changes that occur during the&#xD;
      hemodialysis session will be evaluated.&#xD;
&#xD;
      An increase of blood pressure is correlated with the increase of peripheral vascular&#xD;
      resistance and/or the increase of cardiac output, reflecting an adjustment to the fast&#xD;
      changes in the intravascular volume.&#xD;
&#xD;
      Aim of the study The hemodynamic changes that occur during the dialysis session in patients&#xD;
      with intradialytic hypertension by using the NICAS device will be evaluated.&#xD;
&#xD;
      Methods This will be an observational prospective study that examines hemodynamic parameters&#xD;
      before and immediately after the dialysis session.&#xD;
&#xD;
      The hemodynamic data is collected by the investigators during the study period. These&#xD;
      parameters will be obtained before starting the dialysis session, every hour during the&#xD;
      dialysis session and at the end of it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Peripheral vascular resistance (dyne/sec/cm5)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke volume (ml)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke index (ml/m2)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac output (l/min)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac index (l/min/m2)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate (bpm)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood pressure (mm/Hg)</measure>
    <time_frame>During 3 consecutive hemodialysis session in one week</time_frame>
    <description>In patients with intradialytic hypertension</description>
  </primary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Intradialytic Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty two patients on Chronic Hemodialysis treatment that exhibit intradialytic&#xD;
        hypertension in the dialysis unit in the Galilee Medical Center will be included during&#xD;
        2016-2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intradialytic hypertension at least once weakly&#xD;
&#xD;
          -  Age older than 18 years&#xD;
&#xD;
          -  Chronic hemodialysis treatment more than 3 months&#xD;
&#xD;
          -  Stable dialysis treatment conditions&#xD;
&#xD;
          -  Stable antihypertensive treatment for the last 4 weeks prior the study&#xD;
&#xD;
          -  Patients able and agree to sign the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent changes in the antihypertensive treatment&#xD;
&#xD;
          -  Recent acute cardiovascular event&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Western Galilee Hospital</name>
      <address>
        <city>Nahariya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>June 10, 2019</last_update_submitted>
  <last_update_submitted_qc>June 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Galilee Hospital-Nahariya</investigator_affiliation>
    <investigator_full_name>Khaled Khazim, MD</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>Intradialytic hypertension</keyword>
  <keyword>Hemodynamics changes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03038165
org study id: GMC170114CTIL
nct id: NCT03038165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While the exact pathogenesis of Intradialytic hypertension remains to be determined, several
      mechanisms were proposed to be involved. The main factors to determine the arterial blood
      pressure are the peripheral vascular resistance and cardiac output. The assumption is that
      the increase of blood pressure is related to the increase in peripheral vascular resistance
      during the dialysis session, due to fluid removal and fast reduction of the intravascular
      volume reduction.

      Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients
      with intradialytic hypertension will be evaluated
The number of patients with end stage renal disease (ESRD) is growing worldwide and nowadays
      hemodialysis (HD) treatment is the prevalent modality of renal replacement therapy.
      Paradoxically an increase of BP during or immediately after the HD sessions has been observed
      in some patients. This phenomenon is referred to as Intradialytic Hypertension (IDH). The
      focus will be on systolic BP increase ≥ 10 mmHg during or immediately after hemodialysis
      which results in post-dialysis hypertension BP above ≥130/80 mmHg. IDH affects up to 10-15%
      of hemodialysis patients. Patients with IDH have unfavorable outcomes; previous
      epidemiological data showed that IDH is associated with higher cardiovascular morbidity and
      mortality rates.

      From the view of hemodynamic profile, peripheral resistance and cardiac output are the most
      important factors contributing to arterial blood pressure. The pathogenesis of IDH is likely
      to be multifactorial. Several mechanisms were proposed to be involved in the pathogenesis of
      this phenomenon.

      Endothelial dysfunction, increased activity of the renin angiotensin aldosterone system
      (RAAS) and activation of the sympathetic nervous system had been shown to be involved in the
      increase of blood pressure during Hemodialysis in this group of patients.

      None of these possible explanations or their inter-relationships has been studied in a
      controlled experimental setting and the actual physiological changes during hemodialysis in
      intradialytic hypertensive patients still remain unexplored.

      The NICAS (Non-Invasive Cardiac System) device, used mainly for noninvasive cardiac
      diagnostic purposes, is substantially equivalent to the use of other hemodynamic evaluation
      tools, yet it is non-invasive and provides on-line data regarding the hemodynamic status of
      patients. Using this device, the hemodynamic changes during the HD session of IDH patients
      will be investigated.

      By using the NICAS device, the hemodynamics parameters changes during the dialysis session
      will be measured. The parameters that will be measured are heart rate, stroke volume, cardiac
      index, cardiac power index and total peripheral vascular resistance.

      During the hemodialysis treatment several hemodynamic changes may occur due to intravascular
      volume reduction. Changes in peripheral vascular resistance, cardiac output and cardiac power
      index contribute to the hemodynamic stability during the dialysis session.

      By using a non-invasive technique, the NICAS device,hemodynamic changes that occur during the
      hemodialysis session will be evaluated.

      An increase of blood pressure is correlated with the increase of peripheral vascular
      resistance and/or the increase of cardiac output, reflecting an adjustment to the fast
      changes in the intravascular volume.

      Aim of the study The hemodynamic changes that occur during the dialysis session in patients
      with intradialytic hypertension by using the NICAS device will be evaluated.

      Methods This will be an observational prospective study that examines hemodynamic parameters
      before and immediately after the dialysis session.

      The hemodynamic data is collected by the investigators during the study period. These
      parameters will be obtained before starting the dialysis session, every hour during the
      dialysis session and at the end of it.
observational model: Cohort
time perspective: Prospective
measure: Peripheral vascular resistance (dyne/sec/cm5)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
measure: Stroke volume (ml)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
measure: Stroke index (ml/m2)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
measure: Cardiac output (l/min)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
measure: Cardiac index (l/min/m2)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
measure: Heart rate (bpm)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
measure: blood pressure (mm/Hg)
time frame: During 3 consecutive hemodialysis session in one week
description: In patients with intradialytic hypertension
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Western Galilee Hospital-Nahariya
investigator full name: Khaled Khazim, MD
investigator title: Principle investigator
mesh term: Hypertension
sharing ipd: No