xml: <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/NCT05990907</url>
    </required_header>
    <id_info>
      <org_study_id>RIC-KIP</org_study_id>
      <nct_id>NCT05990907</nct_id>
    </id_info>
    <brief_title>Influence of RIC on the Orthostatic Competence of the Microcirculation</brief_title>
    <official_title>Pilot Study: Influence of Ischemic Preconditioning on the Orthostatic Competence of the Microcirculation in the Lower Extremity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ISAR Klinikum</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ISAR Klinikum</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>
        The goal of this clinical trial (pilot study) is to learn about the microcirculatory&#xD;
        regulation of the lower extremity under orthostatic stress with and without RIC - Remote&#xD;
        Ischemic Preconditioning in healthy participants. The main question it aims to answer are:&#xD;
  &#xD;
        Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower&#xD;
        extremity microcirculation in ortho-statically stressed subjects? Is there a&#xD;
        relationship/correlation between the variables of microcirculation and hemodynamics in the&#xD;
        context of RIC and orthostatic loading?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of free flaps is a standard procedure in reconstructive plastic surgery, in which a&#xD;
        wide variety of tissue units are microsurgically transplanted, often to cover defects on the&#xD;
        body surface. Microvascular tissue transplants depend on an adequate blood supply, which is&#xD;
        particularly vulnerable in the first postoperative phase. In the case of reconstructions of&#xD;
        the lower extremities in particular, the flap perfusion is stressed during the first&#xD;
        mobilizations due to the orthostatic load. For this reason, the mobilization of the patients&#xD;
        is gradually increased from day to day with precise monitoring of the blood flow (so-called&#xD;
        flap training).&#xD;
  &#xD;
        A procedure for temporarily improving the blood flow in free flaps is ischemic&#xD;
        preconditioning (RIC - Remote Ischemic Preconditioning). Repeated, short cycles of&#xD;
        ischemia/reperfusion applied to a circumscribed vascular territory (e.g. supra systolic&#xD;
        tourniquet arm) lead to an increase in tissue perfusion, even outside the area of application&#xD;
        (arm).&#xD;
  &#xD;
        RIC could have the potential to optimize the tissue perfusion of flaps even under orthostatic&#xD;
        stress and to promote an earlier mobilization of patients. Our work investigates the&#xD;
        influence of RIC on orthostatic competence (as part of a standardized orthostatic load with a&#xD;
        tilting table) of the microcirculatory system in the lower extremities and the orthostatic&#xD;
        hemodynamic regulation itself.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 30, 2023</start_date>
    <completion_date type="Anticipated">August 13, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 10, 2023</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>
      <intervention_model_description>The research project is a controlled, single-arm, monocentric clinical study. Due to the study design, randomization and blinding are not possible.&#xD;
  Unfortunately, there is no scientific data on how long the effects of ischemic preconditioning last. Thus, in a cross-over design study with protocols 1 and 2 in a different order, there would be a risk or bias that subjects who received ischemic preconditioning in the first measurement would have this effect in the second measurement. For this reason, we decided on a standardized procedure for measurement 1 (without ischemic preconditioning) and measurement 2 (with ischemic preconditioning). In this case, the study design would be one-armed.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Due to the study design, randomization and blinding are not possible.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Microcirculation parameters</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units [AU]</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Microcirculation parameters - oxygen saturation</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) capillary venous oxygen saturation in percent (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microcirculation parameters - Relative amount of hemoglobin</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative amount of hemoglobin in arbitrary units [AU]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemodynamics</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>hemodynamics parameters: systolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemodynamics</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>hemodynamics parameters: mean arterial blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemodynamics</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>hemodynamics parameters: diastolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemodynamics</measure>
      <time_frame>continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment</time_frame>
      <description>hemodynamics parameters: heart rate in beats per minute (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Microcirculation</condition>
    <condition>Orthostatic Intolerance</condition>
    <condition>Remote Ischemic Preconditioning</condition>
    <condition>Hemodynamics</condition>
    <arm_group>
      <arm_group_label>Tilting table without and with RIC</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The experimental setup consists of two separate measurements. In the first measurement, the subject is ortho-statically stressed by changing the position (lying to upright) on a tilting table (similar to the established tilting table test). 24 hours after the first measurement, the ischemic preconditioning will be carried out in three cycles with a directly subsequent tilting table test.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Remote ischemic preconditioning</intervention_name>
      <description>The empty tourniquet (VBM Tourniquet Touch®, Sulz a.N. Germany) is attached to the right upper arm. The measurement starts from this point in time. After lying flat for 10 minutes, the upper arm tourniquet is inflated to 250 mmHg. In all subjects, the ischemia was verified by palpation and Doppler signal of the radial artery. The ischemia phase is carried out for 10 minutes, so the tourniquet is opened and a 10-minute reperfusion phase is started, followed by a total of 3 cycles. After the 3rd ischemia phase, the tilting table test is followed by a 15-minute lying interval.</description>
      <arm_group_label>Tilting table without and with RIC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-smokers&#xD;
  &#xD;
            -  No diseases relevant to circulation and blood flow (arterial hypertension, peripheral&#xD;
               arterial occlusive disease, chronic venous insufficiency)&#xD;
  &#xD;
            -  Subjects must be capable of insight. Anyone who can understand the nature,&#xD;
               significance, and scope of the clinical trial and determine their will accordingly is&#xD;
               capable of insight.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-consent&#xD;
  &#xD;
            -  Lack of compliance&#xD;
  &#xD;
            -  Syncope tendency&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ulf Dornseifer, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Department Plastic Surgery ISAR Klinikum, Munich</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>ISAR Klinikum</name>
        <address>
          <city>Munich</city>
          <state>Bavaria</state>
          <zip>80331</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>ISAR Klinikum</investigator_affiliation>
      <investigator_full_name>Peter Paul Pfeiler, MD</investigator_full_name>
      <investigator_title>chief resident</investigator_title>
    </responsible_party>
    <keyword>Microcirculation</keyword>
    <keyword>Remote ischemic preconditioning</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Orthostatic Intolerance</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT05990907/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990907
  org study id: RIC-KIP
  nct id: NCT05990907
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial (pilot study) is to learn about the microcirculatory
        regulation of the lower extremity under orthostatic stress with and without RIC - Remote
        Ischemic Preconditioning in healthy participants. The main question it aims to answer are:
  
        Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower
        extremity microcirculation in ortho-statically stressed subjects? Is there a
        relationship/correlation between the variables of microcirculation and hemodynamics in the
        context of RIC and orthostatic loading?
  The use of free flaps is a standard procedure in reconstructive plastic surgery, in which a
        wide variety of tissue units are microsurgically transplanted, often to cover defects on the
        body surface. Microvascular tissue transplants depend on an adequate blood supply, which is
        particularly vulnerable in the first postoperative phase. In the case of reconstructions of
        the lower extremities in particular, the flap perfusion is stressed during the first
        mobilizations due to the orthostatic load. For this reason, the mobilization of the patients
        is gradually increased from day to day with precise monitoring of the blood flow (so-called
        flap training).
  
        A procedure for temporarily improving the blood flow in free flaps is ischemic
        preconditioning (RIC - Remote Ischemic Preconditioning). Repeated, short cycles of
        ischemia/reperfusion applied to a circumscribed vascular territory (e.g. supra systolic
        tourniquet arm) lead to an increase in tissue perfusion, even outside the area of application
        (arm).
  
        RIC could have the potential to optimize the tissue perfusion of flaps even under orthostatic
        stress and to promote an earlier mobilization of patients. Our work investigates the
        influence of RIC on orthostatic competence (as part of a standardized orthostatic load with a
        tilting table) of the microcirculatory system in the lower extremities and the orthostatic
        hemodynamic regulation itself.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The research project is a controlled, single-arm, monocentric clinical study. Due to the study design, randomization and blinding are not possible.
  Unfortunately, there is no scientific data on how long the effects of ischemic preconditioning last. Thus, in a cross-over design study with protocols 1 and 2 in a different order, there would be a risk or bias that subjects who received ischemic preconditioning in the first measurement would have this effect in the second measurement. For this reason, we decided on a standardized procedure for measurement 1 (without ischemic preconditioning) and measurement 2 (with ischemic preconditioning). In this case, the study design would be one-armed.
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: Due to the study design, randomization and blinding are not possible.
  measure: Microcirculation parameters
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units [AU]
  measure: Microcirculation parameters - oxygen saturation
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) capillary venous oxygen saturation in percent (%)
  measure: Microcirculation parameters - Relative amount of hemoglobin
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative amount of hemoglobin in arbitrary units [AU]
  measure: Hemodynamics
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: hemodynamics parameters: systolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
  measure: Hemodynamics
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: hemodynamics parameters: mean arterial blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
  measure: Hemodynamics
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: hemodynamics parameters: diastolic blood pressure in mmHg (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
  measure: Hemodynamics
  time frame: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
  description: hemodynamics parameters: heart rate in beats per minute (Measured with Finapres® NOVA, Finapres Medical Systems BV, Enschede, Netherlands)
  arm group label: Tilting table without and with RIC
  arm group type: Other
  description: The experimental setup consists of two separate measurements. In the first measurement, the subject is ortho-statically stressed by changing the position (lying to upright) on a tilting table (similar to the established tilting table test). 24 hours after the first measurement, the ischemic preconditioning will be carried out in three cycles with a directly subsequent tilting table test.
  intervention type: Procedure
  intervention name: Remote ischemic preconditioning
  description: The empty tourniquet (VBM Tourniquet Touch®, Sulz a.N. Germany) is attached to the right upper arm. The measurement starts from this point in time. After lying flat for 10 minutes, the upper arm tourniquet is inflated to 250 mmHg. In all subjects, the ischemia was verified by palpation and Doppler signal of the radial artery. The ischemia phase is carried out for 10 minutes, so the tourniquet is opened and a 10-minute reperfusion phase is started, followed by a total of 3 cycles. After the 3rd ischemia phase, the tilting table test is followed by a 15-minute lying interval.
  arm group label: Tilting table without and with RIC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ulf Dornseifer, MD, PhD
  role: Study Chair
  affiliation: Department Plastic Surgery ISAR Klinikum, Munich
  facility: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: ISAR Klinikum
  investigator full name: Peter Paul Pfeiler, MD
  investigator title: chief resident
  mesh term: Orthostatic Intolerance
  mesh term: Ischemia
  sharing ipd: No
  provided document: 