<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/NCT02996188</url>
  </required_header>
  <id_info>
    <org_study_id>IGR-paracentesis</org_study_id>
    <nct_id>NCT02996188</nct_id>
  </id_info>
  <brief_title>Acute Hemodynamic Changes During Paracentesis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsmedizin Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsmedizin Mannheim</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense&#xD;
      ascites using non-invasive inert gas rebreathing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in cardiac output</measure>
    <time_frame>30 minutes</time_frame>
    <description>prior to and after paracentesis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in systemic vascular resistance</measure>
    <time_frame>30 minutes</time_frame>
    <description>prior to and after paracentesis</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Tense Ascites</condition>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Patients with refractory tense ascites</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>routine therapeutic paracentesis</intervention_name>
    <arm_group_label>Patients with refractory tense ascites</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing routine therapeutic paracentesis due to refractory tense ascites at a&#xD;
        university hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  refractory tense ascites with indication for therapeutic paracentesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inability to give inform consent&#xD;
&#xD;
          -  inability to perform rebreathing maneuver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsmedizin Mannheim</investigator_affiliation>
    <investigator_full_name>Joachim Saur</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Ascites</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02996188
org study id: IGR-paracentesis
nct id: NCT02996188
lead sponsor: 
has dmc: Yes
The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense
      ascites using non-invasive inert gas rebreathing.
observational model: Cohort
time perspective: Prospective
measure: change in cardiac output
time frame: 30 minutes
description: prior to and after paracentesis
measure: change in systemic vascular resistance
time frame: 30 minutes
description: prior to and after paracentesis
arm group label: Patients with refractory tense ascites
intervention type: Procedure
intervention name: routine therapeutic paracentesis
arm group label: Patients with refractory tense ascites
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Joachim Saur
investigator title: Principal Investigator
mesh term: Liver Cirrhosis
mesh term: Ascites
sharing ipd: No