<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/NCT02993640</url>
  </required_header>
  <id_info>
    <org_study_id>EPN879-13</org_study_id>
    <nct_id>NCT02993640</nct_id>
  </id_info>
  <brief_title>Optimization of Hepatic Hemodynamics During Liver Surgery</brief_title>
  <official_title>Effects of Vasopressin and Nitroglycerine in Combination on Splanchnic Blood Flow, and on Hepatic and Portal Venous Pressures in Liver Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if vasopressin and nitroglycerin in combination&#xD;
      will affect hepatic hemodynamics, in the setting of liver surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients in this study (undergoing elective liver resection) will be anesthetized&#xD;
      according to routine practice in our hospital. A radial arterial catheter and a central&#xD;
      venous catheter will be inserted, as well as a femoral arterial catheter for Picco&#xD;
      monitoring. After the dissection phase, catheters will be inserted in the portal and hepatic&#xD;
      veins by the surgeon. Base line data (HR, CVP, MAP, CO from thermodilution, portal and&#xD;
      hepatic venous pressure, blood gases from radial artery, vena cava superior, hepatic vein and&#xD;
      portal vein) will be obtained twice, with 10 minutes of steady state in between. An infusion&#xD;
      of vasopressin 4,8 U/h will then be started and continued for 20 minutes. Data will be&#xD;
      collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be&#xD;
      added. After 5 minutes of steady MAP 55-65, the last set of data is collected. 12 Patients&#xD;
      will be recruited, and the total data collection is estimated to be completed and assessed&#xD;
      after six to nine months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 20, 2017</primary_completion_date>
  <phase>Early Phase 1</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Portal and hepatic venous flow after vasopressin and nitroglycerine infusion</measure>
    <time_frame>six - nine months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion</measure>
    <time_frame>six - nine months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>lactate in the splanchnic circulation</measure>
    <time_frame>six-nine months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Portal Blood Pressure</condition>
  <condition>Liver Surgery</condition>
  <condition>Hepatic Hemodynamics</condition>
  <arm_group>
    <arm_group_label>vasopressin + nitro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vasopressin + nitroglycerin in simultaneous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vasopressin + nitro</intervention_name>
    <description>vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.</description>
    <arm_group_label>vasopressin + nitro</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients within ASA-class I-II scheduled for open liver resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA-class III and IV, more than 2 medications for hypertension, BMI &gt; 35, technical&#xD;
             difficulties with insertion av catheters, extensive surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven-Erik Ricksten, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>November 6, 2018</last_update_submitted>
  <last_update_submitted_qc>November 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Ellinor Wisén</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>vasopressin</keyword>
  <keyword>nitroglycerine</keyword>
  <keyword>portal pressure</keyword>
  <keyword>portal flow</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans of sharing IPD</ipd_description>
  </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/NCT02993640
org study id: EPN879-13
nct id: NCT02993640
lead sponsor: 
has dmc: No
The purpose of this study is to determine if vasopressin and nitroglycerin in combination
      will affect hepatic hemodynamics, in the setting of liver surgery.
The patients in this study (undergoing elective liver resection) will be anesthetized
      according to routine practice in our hospital. A radial arterial catheter and a central
      venous catheter will be inserted, as well as a femoral arterial catheter for Picco
      monitoring. After the dissection phase, catheters will be inserted in the portal and hepatic
      veins by the surgeon. Base line data (HR, CVP, MAP, CO from thermodilution, portal and
      hepatic venous pressure, blood gases from radial artery, vena cava superior, hepatic vein and
      portal vein) will be obtained twice, with 10 minutes of steady state in between. An infusion
      of vasopressin 4,8 U/h will then be started and continued for 20 minutes. Data will be
      collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be
      added. After 5 minutes of steady MAP 55-65, the last set of data is collected. 12 Patients
      will be recruited, and the total data collection is estimated to be completed and assessed
      after six to nine months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Portal and hepatic venous flow after vasopressin and nitroglycerine infusion
time frame: six - nine months
measure: Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion
time frame: six - nine months
measure: lactate in the splanchnic circulation
time frame: six-nine months
arm group label: vasopressin + nitro
arm group type: Experimental
description: vasopressin + nitroglycerin in simultaneous infusion
intervention type: Drug
intervention name: vasopressin + nitro
description: vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.
arm group label: vasopressin + nitro
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sven-Erik Ricksten, Professor
role: Study Director
affiliation: Sahlgrenska University Hospital, Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Ellinor Wisén
investigator title: MD
mesh term: Vasopressins
mesh term: Arginine Vasopressin
sharing ipd: No
ipd description: No plans of sharing IPD