<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/NCT01703442</url>
  </required_header>
  <id_info>
    <org_study_id>EPERIA</org_study_id>
    <nct_id>NCT01703442</nct_id>
  </id_info>
  <brief_title>Intraoperative Anuric Episodes in Patients Undergoing Laparotomy</brief_title>
  <official_title>Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claudia Spies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-center prospective observational study. This study examines urine flow and&#xD;
      haemodynamic parameters during abdominal surgery and analyses the association to&#xD;
      postoperative renal function and markers and to postoperative clinical outcome.&#xD;
&#xD;
      Primary hypothesis:&#xD;
&#xD;
      • Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are&#xD;
      phases of temporary anuria.&#xD;
&#xD;
      Secondary hypothesis:&#xD;
&#xD;
        -  Perioperative anuric phases are directly associated to the postoperative increase of&#xD;
           NGAL (neutrophil gelatinase-associated lipocalin) and creatinine&#xD;
&#xD;
        -  Perioperative renal dysfunction is directly associated to postoperative complications&#xD;
           and functional recovery of patients&#xD;
&#xD;
        -  A response of urine flow to a standardized postoperative diuretic bolus can identify&#xD;
           patients who benefit from a pharmaceutical fluid mobilization&#xD;
&#xD;
        -  Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the&#xD;
           methods for the measurement of stroke volume of the heart differ&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Exact measurement of urine production</measure>
    <time_frame>During the operation and in the 72-hour postoperative sample period</time_frame>
    <description>Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exact measurement of urine production</measure>
    <time_frame>During the operation and in the 72-hour postoperative sample period</time_frame>
    <description>Exact measurement of urine production (amount in milliliter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine</measure>
    <time_frame>During the operation and in the 72-hour postoperative sample period</time_frame>
    <description>Parameters from blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>During the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>During the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depth of Anesthesia</measure>
    <time_frame>During the operation</time_frame>
    <description>Measuring depth of Anesthesia by Bispectral Index Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ dysfunctions</measure>
    <time_frame>During the operation and in the 72-hour postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>In the 72-hour postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight development</measure>
    <time_frame>In the 72-hour postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration until fulfilment of hospital discharge criteria</measure>
    <time_frame>Participants will be followed for the duration of an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU and hospital length of stay</measure>
    <time_frame>Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and functional status</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory parameters</measure>
    <time_frame>In the 72-hour postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of vasopressors</measure>
    <time_frame>During the operation and in the 72-hour postoperative sample period</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Intraoperative Anuria</condition>
  <arm_group>
    <arm_group_label>Ovarian cancer patients</arm_group_label>
    <description>Perioperative primary epithelial ovarian cancer patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients being treated in the Department of Gynecology and Obstetrics, Campus&#xD;
        Virchow Klinikum, Charité - Universitaetsmedizin Berlin.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Offered patient information and written informed consent&#xD;
&#xD;
          -  Female patients aged greater than or equal to 18 years for cytoreductive surgery of a&#xD;
             primary epithelial ovarian tumour&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with relapse Ovarian Cancer&#xD;
&#xD;
          -  Patients aged less than 18 years&#xD;
&#xD;
          -  Persons without the capacity to consent&#xD;
&#xD;
          -  Unability of German language use&#xD;
&#xD;
          -  Lacking willingness to save and hand out data within the study&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  (Unclear) history of alcohol or substances disabuse&#xD;
&#xD;
          -  Coworker of the Charité&#xD;
&#xD;
          -  Advanced disease of the oesophagus or upper respiratory tract at the beginning of&#xD;
             hospitalisation&#xD;
&#xD;
          -  Operation in the area of the oesophagus or nasopharynx within the last two months&#xD;
             before participation in the study&#xD;
&#xD;
          -  Neurological or psychiatric disease at the beginning of hospitalisation&#xD;
&#xD;
          -  CHF (congestive heart failure) according to (New York Heart Association)&#xD;
             classification - NYHA class IV at the beginning of hospitalisation&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) classification greater than IV&#xD;
&#xD;
          -  Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalisation&#xD;
&#xD;
          -  Pulmonal oedema in thorax x-ray at the beginning of hospitalisation&#xD;
&#xD;
          -  History of intracranial hemorrhage within one year before participation in the study&#xD;
&#xD;
          -  Conditions following venous thrombosis within the last three years before study&#xD;
             inclusion&#xD;
&#xD;
          -  Known allergies or hypersensitivity on colloidal, starch or gelatine infusion&#xD;
             solutions&#xD;
&#xD;
          -  Diabetes mellitus with signs of severe neuropathy&#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>Claudia Spies, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>August 10, 2016</last_update_submitted>
  <last_update_submitted_qc>August 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anuria</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/NCT01703442
org study id: EPERIA
nct id: NCT01703442
lead sponsor: 
has dmc: No
A single-center prospective observational study. This study examines urine flow and
      haemodynamic parameters during abdominal surgery and analyses the association to
      postoperative renal function and markers and to postoperative clinical outcome.

      Primary hypothesis:

      • Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are
      phases of temporary anuria.

      Secondary hypothesis:

        -  Perioperative anuric phases are directly associated to the postoperative increase of
           NGAL (neutrophil gelatinase-associated lipocalin) and creatinine

        -  Perioperative renal dysfunction is directly associated to postoperative complications
           and functional recovery of patients

        -  A response of urine flow to a standardized postoperative diuretic bolus can identify
           patients who benefit from a pharmaceutical fluid mobilization

        -  Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the
           methods for the measurement of stroke volume of the heart differ
observational model: Cohort
time perspective: Prospective
measure: Exact measurement of urine production
time frame: During the operation and in the 72-hour postoperative sample period
description: Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)
measure: Exact measurement of urine production
time frame: During the operation and in the 72-hour postoperative sample period
description: Exact measurement of urine production (amount in milliliter)
measure: Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine
time frame: During the operation and in the 72-hour postoperative sample period
description: Parameters from blood sample
measure: Hemodynamic parameters
time frame: During the operation
measure: Blood loss
time frame: During the operation
measure: Depth of Anesthesia
time frame: During the operation
description: Measuring depth of Anesthesia by Bispectral Index Monitoring
measure: Organ dysfunctions
time frame: During the operation and in the 72-hour postoperative sample period
measure: Postoperative pain
time frame: In the 72-hour postoperative sample period
measure: Body weight development
time frame: In the 72-hour postoperative sample period
measure: Duration until fulfilment of hospital discharge criteria
time frame: Participants will be followed for the duration of an expected average of 4 weeks
measure: ICU and hospital length of stay
time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Quality of life and functional status
time frame: Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks
measure: Inflammatory parameters
time frame: In the 72-hour postoperative sample period
measure: Amount of vasopressors
time frame: During the operation and in the 72-hour postoperative sample period
arm group label: Ovarian cancer patients
description: Perioperative primary epithelial ovarian cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia Spies, MD, Prof.
role: Study Director
affiliation: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
mesh term: Anuria