<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/NCT02264522</url>
  </required_header>
  <id_info>
    <org_study_id>04-14-39</org_study_id>
    <nct_id>NCT02264522</nct_id>
  </id_info>
  <brief_title>Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration</brief_title>
  <official_title>Use of Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Ultrafiltration in Hemodialysis Patients to Achieve Euvolemia While Minimizing Intra-dialytic Hypotension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intelomed, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Dialysis Care, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Intelomed, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide&#xD;
      the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to&#xD;
      further the investigators understanding of homeostasis in hemodialysis.&#xD;
&#xD;
      The investigators hypothesize that the signals generated from the PPG device along with&#xD;
      traditional monitoring and nursing judgment, will allow experienced, oriented staff to&#xD;
      anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic&#xD;
      hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that&#xD;
      preclude the patient from achieving an appropriate post-dialysis weight consistent with&#xD;
      euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to&#xD;
      wean patients from anti-hypertensive medications and craft patient specific dialysis orders&#xD;
      and UF profiles that achieve consistent, comfortable treatment to appropriate end points.&#xD;
&#xD;
      The study aims include:&#xD;
&#xD;
      Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine&#xD;
      hemodialysis.&#xD;
&#xD;
      Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac&#xD;
      event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to&#xD;
      reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.&#xD;
&#xD;
      Aim 4: To develop care paths approved by the medical staff and primary care nephrologist&#xD;
      allowing RNs to respond to signals from the PPG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between prescribed dry weight and actual measured weight at end of dialysis session.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Percent difference between prescribed dry weight and actual weight at end of dialysis session.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Intradialytic Hypotension</condition>
  <condition>Hypervolemia</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be enrolled in the same intervention arm. Interventions are implemented based in 1-4 event levels on the device. Interventions include: &quot;Place dialysis chair into position 3&quot;, &quot;Decrease dialysate temperature&quot;, &quot;Decrease ultrafiltration rate by 25%&quot;, and &quot;Decrease ultrafiltration rate by 50%&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Place dialysis chair into position 3.</intervention_name>
    <description>Upon device notification event 1, place patient in dialysis chair position 3.</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decrease dialysate temperature.</intervention_name>
    <description>Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decrease ultrafiltration rate by 25%.</intervention_name>
    <description>Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decrease ultrafiltration rate by 50%.</intervention_name>
    <description>Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;18 years&#xD;
&#xD;
          2. On dialysis &gt; 6 months with a stable dialysis program&#xD;
&#xD;
          3. Consistent achievement of a spKt/V ≥ 1.2&#xD;
&#xD;
          4. HGB ≥ 10 gm% ± ESA support&#xD;
&#xD;
          5. Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg&#xD;
&#xD;
          6. Able to give informed consent directly&#xD;
&#xD;
          7. Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)&#xD;
&#xD;
               -  Symptoms of hypotension&#xD;
&#xD;
               -  Intervention administered because of IDH (saline, &quot;turn downs, early termination,&#xD;
                  trendelenberg position)&#xD;
&#xD;
               -  Drop in BP irrespective of symptoms. SBP &lt; 90 mmHG intra or post HD if pre SBP&#xD;
                  was &gt; 110 mmHG; SBP &lt; 85 mmHG or 15 mmHG drop from start if starting BP ≤ 110&#xD;
                  mmHG.&#xD;
&#xD;
               -  Or judged by the nursing staff to be difficult to achieve dry weight.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Dialysis Catheter Access that may interfere with continuous data collection, per PI&#xD;
             determination. (Catheter access is a relative exclusion based on the history of&#xD;
             catheter performance.)&#xD;
&#xD;
          2. Cognitive Impairment precluding cooperation, and consent&#xD;
&#xD;
          3. Restless or unlikely to wear the monitor head-band&#xD;
&#xD;
          4. Too unstable in the judgment of their nephrologist to be included in a study of this&#xD;
             nature.&#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>Centers for Dialysis Care - East</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>August 28, 2016</last_update_submitted>
  <last_update_submitted_qc>August 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dialysis Solutions</mesh_term>
  </intervention_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/NCT02264522
org study id: 04-14-39
nct id: NCT02264522
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide
      the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to
      further the investigators understanding of homeostasis in hemodialysis.

      The investigators hypothesize that the signals generated from the PPG device along with
      traditional monitoring and nursing judgment, will allow experienced, oriented staff to
      anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic
      hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that
      preclude the patient from achieving an appropriate post-dialysis weight consistent with
      euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to
      wean patients from anti-hypertensive medications and craft patient specific dialysis orders
      and UF profiles that achieve consistent, comfortable treatment to appropriate end points.

      The study aims include:

      Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine
      hemodialysis.

      Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac
      event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to
      reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.

      Aim 4: To develop care paths approved by the medical staff and primary care nephrologist
      allowing RNs to respond to signals from the PPG.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difference between prescribed dry weight and actual measured weight at end of dialysis session.
time frame: 8 weeks
description: Percent difference between prescribed dry weight and actual weight at end of dialysis session.
arm group label: Single Arm
arm group type: Experimental
description: All patients will be enrolled in the same intervention arm. Interventions are implemented based in 1-4 event levels on the device. Interventions include: "Place dialysis chair into position 3", "Decrease dialysate temperature", "Decrease ultrafiltration rate by 25%", and "Decrease ultrafiltration rate by 50%".
intervention type: Other
intervention name: Place dialysis chair into position 3.
description: Upon device notification event 1, place patient in dialysis chair position 3.
arm group label: Single Arm
intervention type: Other
intervention name: Decrease dialysate temperature.
description: Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.
arm group label: Single Arm
intervention type: Other
intervention name: Decrease ultrafiltration rate by 25%.
description: Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.
arm group label: Single Arm
intervention type: Other
intervention name: Decrease ultrafiltration rate by 50%.
description: Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.
arm group label: Single Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypotension
mesh term: Dialysis Solutions
sharing ipd: No