<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/NCT02227329</url>
  </required_header>
  <id_info>
    <org_study_id>13-007793</org_study_id>
    <nct_id>NCT02227329</nct_id>
  </id_info>
  <brief_title>Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition</brief_title>
  <acronym>ELT</acronym>
  <official_title>Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being implemented to identify the role of prophylactic use of ethanol lock in&#xD;
      adult patients on home parenteral nutrition (HPN). Central catheter related blood stream&#xD;
      infection is a major complication in patients on HPN. The investigators hypothesize that the&#xD;
      prophylactic use of ELT will decrease the number of catheter related blood stream infections&#xD;
      compared to the control group. The investigators further hypothesize that with the&#xD;
      introduction of prophylactic ELT, the number of infections will decrease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral&#xD;
      nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs&#xD;
      may also result in the need for central venous catheter (CVC) removal and replacement.&#xD;
      Current literature supports the use of antibiotics locks in patients with repeated CRBSI.&#xD;
      There is a growing concern about the increased risk of microbial resistance with the long&#xD;
      term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and&#xD;
      includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi.&#xD;
      Compared with antibiotic and other solution locks, which have limitations, ELT has excellent&#xD;
      broad-spectrum bactericidal and fungicidal killing action and poses no problems with&#xD;
      development of resistance over time. There is a lack of a randomized controlled study to&#xD;
      characterize the role of ELT in adult patients on HPN.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Publication of guidelines advising against the use of ethanol locks.&#xD;
  </why_stopped>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Catheter-Related Blood Stream Infections</measure>
    <time_frame>1 year</time_frame>
    <description>The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and &gt;1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Catheter-related Bloodstream Infection (CRBSI) Nos</condition>
  <condition>Bloodstream Infection Due to Central Venous Catheter</condition>
  <condition>Bloodstream Infection Due to Hickman Catheter</condition>
  <arm_group>
    <arm_group_label>Ethanol Lock and Normal Saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heparin and Normal Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethanol</intervention_name>
    <description>Prophylactic ELT will be administered at the time when the HPN is not being infused.</description>
    <arm_group_label>Ethanol Lock and Normal Saline</arm_group_label>
    <other_name>Alcohol lock</other_name>
    <other_name>Ethanol (EtOH)</other_name>
    <other_name>ELT therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin Lock</intervention_name>
    <description>3 mL of 100 U/ml heparin</description>
    <arm_group_label>Heparin and Normal Saline</arm_group_label>
    <other_name>Hep-Lock</other_name>
    <other_name>Heparin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <arm_group_label>Ethanol Lock and Normal Saline</arm_group_label>
    <arm_group_label>Heparin and Normal Saline</arm_group_label>
    <other_name>N Saline</other_name>
    <other_name>0.9 N saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly started on Home parenteral Nutrition and anticipated duration &gt;3 months.&#xD;
&#xD;
          -  Not previously on Home Parenteral Nutrition.&#xD;
&#xD;
          -  Providing consent.&#xD;
&#xD;
          -  Patients with non-medicare insurance.&#xD;
&#xD;
          -  Patients with medicare insurance and a supplementary insurance.&#xD;
&#xD;
          -  Patients with single lumen Hickman® catheters.&#xD;
&#xD;
          -  No known alcohol addiction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to provide consent&#xD;
&#xD;
          -  Patients with medicare insurance and no other supplemental private insurance&#xD;
&#xD;
          -  Patients with a catheter type other than a single lumen Hickman®&#xD;
&#xD;
          -  Patients who are on HPN for less than three months&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients who have previous proven addiction and dependence to alcohol.&#xD;
&#xD;
          -  Patients lacking capacity to provide consent&#xD;
&#xD;
          -  Patients who are not be managed by HPN team at investigator's institution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Hurt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Salonen BR, Bonnes SL, Vallumsetla N, Varayil JE, Mundi MS, Hurt RT. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients. Clin Nutr. 2018 Aug;37(4):1181-1185. doi: 10.1016/j.clnu.2017.05.009. Epub 2017 May 17.</citation>
    <PMID>28576557</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>August 7, 2017</results_first_submitted>
  <results_first_submitted_qc>November 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2017</results_first_posted>
  <last_update_submitted>November 13, 2017</last_update_submitted>
  <last_update_submitted_qc>November 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Ryan T. Hurt, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Home Parenteral Nutrition</keyword>
  <keyword>Infection Prevention</keyword>
  <keyword>CRBSI</keyword>
  <keyword>Ethanol Lock Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This clinical trial was carried out from July 2014 to April 2016 at the Mayo Clinic in Rochester, Minnesota.</recruitment_details>
      <pre_assignment_details>39 subjects were consented, but one subject was excluded after enrollment due to incompatibility with ongoing treatment (ongoing metronidazole use).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ethanol Lock and Normal Saline</title>
          <description>All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.</description>
        </group>
        <group group_id="P2">
          <title>Heparin and Normal Saline</title>
          <description>All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ethanol Lock and Normal Saline</title>
          <description>All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.</description>
        </group>
        <group group_id="B2">
          <title>Heparin and Normal Saline</title>
          <description>All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" spread="16"/>
                    <measurement group_id="B2" value="52" spread="16"/>
                    <measurement group_id="B3" value="51" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Catheter-Related Blood Stream Infections</title>
        <description>The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and &gt;1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ethanol Lock and Normal Saline</title>
            <description>All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.</description>
          </group>
          <group group_id="O2">
            <title>Heparin and Normal Saline</title>
            <description>All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Catheter-Related Blood Stream Infections</title>
          <description>The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and &gt;1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.</description>
          <units>infections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ethanol Lock and Normal Saline</title>
          <description>All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.</description>
        </group>
        <group group_id="E2">
          <title>Heparin and Normal Saline</title>
          <description>All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter-related bloodstream infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on chronic intestinal failure in adults advising against ELT, we conducted an interim analysis. The study was terminated early; further study would not change outcome.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Ryan Hurt</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-4461</phone>
      <email>Hurt.Ryan@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02227329
org study id: 13-007793
nct id: NCT02227329
lead sponsor: 
has dmc: Yes
This study is being implemented to identify the role of prophylactic use of ethanol lock in
      adult patients on home parenteral nutrition (HPN). Central catheter related blood stream
      infection is a major complication in patients on HPN. The investigators hypothesize that the
      prophylactic use of ELT will decrease the number of catheter related blood stream infections
      compared to the control group. The investigators further hypothesize that with the
      introduction of prophylactic ELT, the number of infections will decrease.
Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral
      nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs
      may also result in the need for central venous catheter (CVC) removal and replacement.
      Current literature supports the use of antibiotics locks in patients with repeated CRBSI.
      There is a growing concern about the increased risk of microbial resistance with the long
      term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and
      includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi.
      Compared with antibiotic and other solution locks, which have limitations, ELT has excellent
      broad-spectrum bactericidal and fungicidal killing action and poses no problems with
      development of resistance over time. There is a lack of a randomized controlled study to
      characterize the role of ELT in adult patients on HPN.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Number of Catheter-Related Blood Stream Infections
time frame: 1 year
description: The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.
arm group label: Ethanol Lock and Normal Saline
arm group type: Experimental
description: All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
arm group label: Heparin and Normal Saline
arm group type: Active Comparator
description: All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
intervention type: Drug
intervention name: Ethanol
description: Prophylactic ELT will be administered at the time when the HPN is not being infused.
arm group label: Ethanol Lock and Normal Saline
other name: Alcohol lock
other name: Ethanol (EtOH)
other name: ELT therapy
intervention type: Drug
intervention name: Heparin Lock
description: 3 mL of 100 U/ml heparin
arm group label: Heparin and Normal Saline
other name: Hep-Lock
other name: Heparin
intervention type: Drug
intervention name: Normal Saline
arm group label: Ethanol Lock and Normal Saline
arm group label: Heparin and Normal Saline
other name: N Saline
other name: 0.9 N saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ryan Hurt, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
citation: Salonen BR, Bonnes SL, Vallumsetla N, Varayil JE, Mundi MS, Hurt RT. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients. Clin Nutr. 2018 Aug;37(4):1181-1185. doi: 10.1016/j.clnu.2017.05.009. Epub 2017 May 17.
PMID: 28576557
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Ryan T. Hurt, M.D., Ph.D.
investigator title: Associate Professor of Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis
mesh term: Ethanol
mesh term: Heparin
mesh term: Calcium heparin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on chronic intestinal failure in adults advising against ELT, we conducted an interim analysis. The study was terminated early; further study would not change outcome.
point of contact: 