<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/NCT02219607</url>
  </required_header>
  <id_info>
    <org_study_id>colorectal 1</org_study_id>
    <nct_id>NCT02219607</nct_id>
  </id_info>
  <brief_title>Liver Enzymes and Fluid Balance Following Colorectal Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of epidural anesthesia and postoperative analgesia influences fluid balance following&#xD;
      colorectal surgery.&#xD;
&#xD;
      Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate&#xD;
      intravascular fluid load and predict outcome after colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Anticipated">March 2015</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 liver enzymes</measure>
    <time_frame>5 days postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in BNP (brain natriuretic peptide)</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Fluid Balance</condition>
  <arm_group>
    <arm_group_label>epidural</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>general anesthesia</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing colorectal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing colorectal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiac failure Severe renal failure Severe liver failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ageliki Pandazi, MD,PhD</last_name>
    <phone>00302105832374</phone>
    <email>angpant@med.uoa.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Attikon Hospital</name>
      <address>
        <city>Chaidari</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georgia Kostopanagiotou, MD, PhD</last_name>
      <phone>00302105832372</phone>
    </contact>
    <investigator>
      <last_name>Epistimi Sachitzi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 16, 2014</last_update_submitted>
  <last_update_submitted_qc>August 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Pandazi Ageliki</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02219607
org study id: colorectal 1
nct id: NCT02219607
lead sponsor: 
has dmc: No
The use of epidural anesthesia and postoperative analgesia influences fluid balance following
      colorectal surgery.

      Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate
      intravascular fluid load and predict outcome after colorectal surgery.
observational model: Cohort
time perspective: Prospective
measure: Change in liver enzymes
time frame: 5 days postoperatively
measure: Change in BNP (brain natriuretic peptide)
time frame: 5 days
arm group label: epidural
arm group label: general anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ageliki Pandazi, MD,PhD
phone: 00302105832374
email: angpant@med.uoa.gr
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Pandazi Ageliki
investigator title: Assistant Professor