<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/NCT01727557</url>
  </required_header>
  <id_info>
    <org_study_id>11-08-302</org_study_id>
    <nct_id>NCT01727557</nct_id>
  </id_info>
  <brief_title>Anesthetic Technique for AV Fistulae Creation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to compare the two anesthesia techniques which are commonly used in&#xD;
      the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local&#xD;
      anesthesia means that, your doctor will inject numbing medication directly into the tissue or&#xD;
      part of your body where the surgery will be done. In this case, the numbing medication will&#xD;
      be injected directly into the area where your fistula will be made. In regional anesthesia,&#xD;
      the numbing medication will be injected around the nerve (part of the body that gives&#xD;
      sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare&#xD;
      the three month success rates of AV fistulae created by the two anesthesia techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objectives of the study are:&#xD;
&#xD;
        1. To evaluate the three-month success rate for AV fistulas constructed while using&#xD;
           regional anesthesia against those constructed while using local anesthesia. Success will&#xD;
           be evaluated by a dialysis access ultrasound, which will be performed three months after&#xD;
           completion of the procedure. Successful will be defined as a mean blood flow of 600&#xD;
           ml/min and above, or receiving hemodialysis using the newly created AV fistula.&#xD;
&#xD;
        2. To evaluate the immediate (within 3 days) and long-term complications three months after&#xD;
           AV fistula construction under regional anesthesia or local anesthesia.&#xD;
&#xD;
      The secondary objective of the study is to use a short questionnaire survey To assess patient&#xD;
      comfort level after creation of AV fistula (e.g. nausea, analgesia).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low Accural Rate&#xD;
  </why_stopped>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">July 15, 2016</completion_date>
  <primary_completion_date type="Actual">July 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AV fistula success rate</measure>
    <time_frame>Three months from the day of creation</time_frame>
    <description>To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short term comfort level</measure>
    <time_frame>Within three days of procedure</time_frame>
    <description>To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short term safety, number of post operative complications</measure>
    <time_frame>Three days after the creation</time_frame>
    <description>b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>End Stage Renal Failure on Dialysis</condition>
  <arm_group>
    <arm_group_label>Local anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>regional anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>regional anesthesia</intervention_name>
    <description>Regional anesthesia will be compared to local anesthesia</description>
    <arm_group_label>Local anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>local anesthesia</intervention_name>
    <description>Regional anesthesia will be compared to local anesthesia</description>
    <arm_group_label>regional anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-70 years old&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Creation of first time AV fistula&#xD;
&#xD;
          -  Possible 3 month follow up visit&#xD;
&#xD;
          -  ASA-I-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI ≥40&#xD;
&#xD;
          -  Repeated AV fistula creation,&#xD;
&#xD;
          -  ASA -V,&#xD;
&#xD;
          -  Allergic to local anesthetic agents,&#xD;
&#xD;
          -  Significant lung and cardiac disease,&#xD;
&#xD;
          -  Infection at the site of regional anesthesia,&#xD;
&#xD;
          -  Pre-existing peripheral nerve damage,&#xD;
&#xD;
          -  Significant bleeding disorders,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>June 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>March 1, 2018</last_update_submitted>
  <last_update_submitted_qc>March 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Naum Shaparin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Hemodialysis and AV fistula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT01727557
org study id: 11-08-302
nct id: NCT01727557
lead sponsor: 
has dmc: No
This study is being done to compare the two anesthesia techniques which are commonly used in
      the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local
      anesthesia means that, your doctor will inject numbing medication directly into the tissue or
      part of your body where the surgery will be done. In this case, the numbing medication will
      be injected directly into the area where your fistula will be made. In regional anesthesia,
      the numbing medication will be injected around the nerve (part of the body that gives
      sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare
      the three month success rates of AV fistulae created by the two anesthesia techniques.
The primary objectives of the study are:

        1. To evaluate the three-month success rate for AV fistulas constructed while using
           regional anesthesia against those constructed while using local anesthesia. Success will
           be evaluated by a dialysis access ultrasound, which will be performed three months after
           completion of the procedure. Successful will be defined as a mean blood flow of 600
           ml/min and above, or receiving hemodialysis using the newly created AV fistula.

        2. To evaluate the immediate (within 3 days) and long-term complications three months after
           AV fistula construction under regional anesthesia or local anesthesia.

      The secondary objective of the study is to use a short questionnaire survey To assess patient
      comfort level after creation of AV fistula (e.g. nausea, analgesia).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: AV fistula success rate
time frame: Three months from the day of creation
description: To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
measure: Short term comfort level
time frame: Within three days of procedure
description: To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
measure: Short term safety, number of post operative complications
time frame: Three days after the creation
description: b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.
arm group label: Local anesthesia
arm group type: Active Comparator
arm group label: regional anesthesia
arm group type: Active Comparator
intervention type: Procedure
intervention name: regional anesthesia
description: Regional anesthesia will be compared to local anesthesia
arm group label: Local anesthesia
intervention type: Procedure
intervention name: local anesthesia
description: Regional anesthesia will be compared to local anesthesia
arm group label: regional anesthesia
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Naum Shaparin
investigator title: Assistant Professor
mesh term: Kidney Failure, Chronic
mesh term: Anesthetics