<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/NCT03006939</url>
  </required_header>
  <id_info>
    <org_study_id>FBO</org_study_id>
    <nct_id>NCT03006939</nct_id>
  </id_info>
  <brief_title>Fluid Balance During Surgery for Ovarian Cancer</brief_title>
  <official_title>Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bonn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bonn</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes&#xD;
      survival in late-stage ovarian cancer patients. Little is known about the intraoperative&#xD;
      fluid balance and its impact on morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>fluid balance</measure>
    <time_frame>at the end of surgery</time_frame>
    <description>intraoperative fluid balance is determined by the difference between fluid intake and outtake</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mechanical ventilation</measure>
    <time_frame>at the timepoint of extubation</time_frame>
    <description>Duration of mechanical ventilation, starting from endotracheal intubation until extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>5 years</time_frame>
    <description>long-term mortality after surgery</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ovarian Neoplasm</condition>
  <condition>Fluid Therapy</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cytoreductive surgery</intervention_name>
    <description>Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples are retained to determine the coagulation status as well as the albumine&#xD;
      concentration&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ovarian cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for cytoreductive surgery in ovarian cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  unability to give consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Soehle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinic Bonn</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Soehle, MD, PhD</last_name>
    <phone>0049-228-287-</phone>
    <phone_ext>11378</phone_ext>
    <email>martin.soehle@ukb.uni-bonn.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Soehle, MD, PhD</last_name>
      <phone>++49-228-287</phone>
      <phone_ext>11378</phone_ext>
      <email>martin.soehle@ukb.uni-bonn.de</email>
    </contact>
    <contact_backup>
      <last_name>Claudia Neumann, MD</last_name>
      <phone>++49-228-287</phone>
      <phone_ext>11378</phone_ext>
      <email>claudia.neumann@ukb.uni-bonn.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bonn</investigator_affiliation>
    <investigator_full_name>Martin Soehle</investigator_full_name>
    <investigator_title>Vice head of the department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</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/NCT03006939
org study id: FBO
nct id: NCT03006939
lead sponsor: 
has dmc: No
Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes
      survival in late-stage ovarian cancer patients. Little is known about the intraoperative
      fluid balance and its impact on morbidity and mortality.
observational model: Cohort
time perspective: Prospective
measure: fluid balance
time frame: at the end of surgery
description: intraoperative fluid balance is determined by the difference between fluid intake and outtake
measure: mechanical ventilation
time frame: at the timepoint of extubation
description: Duration of mechanical ventilation, starting from endotracheal intubation until extubation
measure: mortality
time frame: 5 years
description: long-term mortality after surgery
intervention type: Procedure
intervention name: Cytoreductive surgery
description: Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival
Blood samples are retained to determine the coagulation status as well as the albumine
      concentration
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Soehle, MD, PhD
role: Principal Investigator
affiliation: University Clinic Bonn
last name: Martin Soehle, MD, PhD
phone: 0049-228-287-
phone ext: 11378
email: martin.soehle@ukb.uni-bonn.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Martin Soehle
investigator title: Vice head of the department
mesh term: Ovarian Neoplasms
sharing ipd: No