<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/NCT01682889</url>
  </required_header>
  <id_info>
    <org_study_id>MUW_Arginin</org_study_id>
    <nct_id>NCT01682889</nct_id>
  </id_info>
  <brief_title>The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation</brief_title>
  <official_title>The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation: a Randomized, Controlled Clinical Trial in Patients Receiving Peripheral Vascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Scientific Fund of the Mayor of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Scientific Fund of the Mayor of Vienna</source>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on&#xD;
      hemodynamic and on parameters of microcirculation in patients with peripheral arterial&#xD;
      occlusive disease (PAOD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">December 2008</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in temperature gradient at 3h post-surgery</measure>
    <time_frame>baseline and 3h post-surgery</time_frame>
    <description>One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Laser Doppler blood perfusion imaging at 1h</measure>
    <time_frame>baseline &amp; 1h post-surgery</time_frame>
    <description>Perfusion values are expressed as arbitrary perfusion units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Laser Doppler blood perfusion imaging at 2h</measure>
    <time_frame>baseline &amp; 2h post-surgery</time_frame>
    <description>Perfusion values are expressed as arbitrary perfusion units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Laser Doppler blood perfusion imaging at 3h</measure>
    <time_frame>baseline &amp; 3h post-surgery</time_frame>
    <description>Perfusion values are expressed as arbitrary perfusion units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Laser Doppler blood perfusion imaging at 24h</measure>
    <time_frame>baseline &amp; 24h post-surgery</time_frame>
    <description>Perfusion values are expressed as arbitrary perfusion units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Laser Doppler blood perfusion imaging at 48h</measure>
    <time_frame>baseline &amp; 48h post-surgery</time_frame>
    <description>Perfusion values are expressed as arbitrary perfusion units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in asymmetric dimethylarginine (ADMA) at 3h</measure>
    <time_frame>baseline &amp; 3h post-surgery</time_frame>
    <description>Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in asymmetric dimethylarginine (ADMA) at 24h</measure>
    <time_frame>baseline &amp; 24h post-surgery</time_frame>
    <description>Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in asymmetric dimethylarginine (ADMA) at 48h</measure>
    <time_frame>baseline &amp; 48h post-surgery</time_frame>
    <description>Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma arginine concentration at 3h</measure>
    <time_frame>baseline &amp; 3h post-surgery</time_frame>
    <description>L-arginine concentration is measured by HPLC and expressed in µmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma arginine concentration at 24h</measure>
    <time_frame>baseline &amp; 24h post-surgery</time_frame>
    <description>L-arginine concentration is measured by HPLC and expressed in µmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma arginine concentration at 48h</measure>
    <time_frame>baseline &amp; 48h post-surgery</time_frame>
    <description>L-arginine concentration is measured by HPLC and expressed in µmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in temperature gradient at 1h</measure>
    <time_frame>baseline &amp; 1h post-surgery</time_frame>
    <description>One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in temperature gradient at 2h</measure>
    <time_frame>baseline &amp; 2h post-surgery</time_frame>
    <description>One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in temperature gradient at 24h</measure>
    <time_frame>baseline &amp; 24h post-surgery</time_frame>
    <description>One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in temperature gradient at 48h</measure>
    <time_frame>baseline &amp; 48h post-surgery</time_frame>
    <description>One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Peripheral Arterial Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>NaCl 0.9% intravenously for 24 hours after induction of anaesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arginine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Arginine</intervention_name>
    <description>L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours</description>
    <arm_group_label>Arginine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>NaCl 0.9% intravenously for 24h</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female or male patients receiving peripheral bypass surgery&#xD;
&#xD;
          -  age between 55 and 75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metabolic acidosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jörg Michael Hiesmayr, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Ass.-Prof. DI Dr. Barbara Wessner</investigator_full_name>
    <investigator_title>Ass.-Prof. DI Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arterial Occlusive Diseases</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/NCT01682889
org study id: MUW_Arginin
nct id: NCT01682889
lead sponsor: 
The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on
      hemodynamic and on parameters of microcirculation in patients with peripheral arterial
      occlusive disease (PAOD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline in temperature gradient at 3h post-surgery
time frame: baseline and 3h post-surgery
description: One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.
measure: Change from baseline in Laser Doppler blood perfusion imaging at 1h
time frame: baseline & 1h post-surgery
description: Perfusion values are expressed as arbitrary perfusion units.
measure: Change from baseline in Laser Doppler blood perfusion imaging at 2h
time frame: baseline & 2h post-surgery
description: Perfusion values are expressed as arbitrary perfusion units.
measure: Change from baseline in Laser Doppler blood perfusion imaging at 3h
time frame: baseline & 3h post-surgery
description: Perfusion values are expressed as arbitrary perfusion units.
measure: Change from baseline in Laser Doppler blood perfusion imaging at 24h
time frame: baseline & 24h post-surgery
description: Perfusion values are expressed as arbitrary perfusion units.
measure: Change from baseline in Laser Doppler blood perfusion imaging at 48h
time frame: baseline & 48h post-surgery
description: Perfusion values are expressed as arbitrary perfusion units.
measure: Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
time frame: baseline & 3h post-surgery
description: Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
measure: Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
time frame: baseline & 24h post-surgery
description: Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
measure: Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
time frame: baseline & 48h post-surgery
description: Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
measure: Change from baseline in plasma arginine concentration at 3h
time frame: baseline & 3h post-surgery
description: L-arginine concentration is measured by HPLC and expressed in µmol/l.
measure: Change from baseline in plasma arginine concentration at 24h
time frame: baseline & 24h post-surgery
description: L-arginine concentration is measured by HPLC and expressed in µmol/l.
measure: Change from baseline in plasma arginine concentration at 48h
time frame: baseline & 48h post-surgery
description: L-arginine concentration is measured by HPLC and expressed in µmol/l.
measure: Change from baseline in temperature gradient at 1h
time frame: baseline & 1h post-surgery
description: One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.
measure: Change from baseline in temperature gradient at 2h
time frame: baseline & 2h post-surgery
description: One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.
measure: Change from baseline in temperature gradient at 24h
time frame: baseline & 24h post-surgery
description: One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.
measure: Change from baseline in temperature gradient at 48h
time frame: baseline & 48h post-surgery
description: One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.
arm group label: Placebo
arm group type: Placebo Comparator
description: NaCl 0.9% intravenously for 24 hours after induction of anaesthesia
arm group label: Arginine
arm group type: Active Comparator
description: L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia
intervention type: Dietary Supplement
intervention name: Arginine
description: L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
arm group label: Arginine
intervention type: Dietary Supplement
intervention name: Placebo
description: NaCl 0.9% intravenously for 24h
arm group label: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jörg Michael Hiesmayr, Prof. Dr.
role: Study Director
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Ass.-Prof. DI Dr. Barbara Wessner
investigator title: Ass.-Prof. DI Dr.
mesh term: Arterial Occlusive Diseases