<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/NCT01722630</url>
  </required_header>
  <id_info>
    <org_study_id>FRF-2012-DH</org_study_id>
    <nct_id>NCT01722630</nct_id>
  </id_info>
  <brief_title>Renal Function During Laparoscopic Surgery</brief_title>
  <official_title>Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this study was to investigate the cardiac and renal responses to the administration of&#xD;
      different amount of crystalloids, with and without dopamine, during gynaecological&#xD;
      laparoscopic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>estimated glomerular filtration rate, tissue Doppler imaging, E/Ea</measure>
    <time_frame>patients will be followed for the duration of surgery, an expected average of 3 hours</time_frame>
    <description>EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total intra operative diuresis (TID)</measure>
    <time_frame>patients will be followed for the duration of surgery, an expected average of 3 hours</time_frame>
    <description>TID will be measured at the end of surgery</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Intra Operative Fluid Management</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients received intravenously saline solution at 5 ml/Kg/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dopamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>crystalloids</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients received intravenously saline solution at 10 ml/Kg/h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dopamine</intervention_name>
    <arm_group_label>dopamine</arm_group_label>
    <other_name>Revivan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I&#xD;
&#xD;
          -  age 24-42&#xD;
&#xD;
          -  patients undergoing gynaecological laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiovascular diseases&#xD;
&#xD;
          -  renal and endocrine disorders&#xD;
&#xD;
          -  obesity (BMI &gt; 30 Kg/m2)&#xD;
&#xD;
          -  the assumption of drugs that could interfere with renal parameters considered in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic University of the sacred Heart</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Francesca Bevilacqua</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>dopamine</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>fluid management</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dopamine</mesh_term>
  </intervention_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/NCT01722630
org study id: FRF-2012-DH
nct id: NCT01722630
lead sponsor: 
has dmc: No
Aim of this study was to investigate the cardiac and renal responses to the administration of
      different amount of crystalloids, with and without dopamine, during gynaecological
      laparoscopic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: estimated glomerular filtration rate, tissue Doppler imaging, E/Ea
time frame: patients will be followed for the duration of surgery, an expected average of 3 hours
description: EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.
measure: total intra operative diuresis (TID)
time frame: patients will be followed for the duration of surgery, an expected average of 3 hours
description: TID will be measured at the end of surgery
arm group label: control
arm group type: No Intervention
description: Patients received intravenously saline solution at 5 ml/Kg/h
arm group label: dopamine
arm group type: Experimental
description: Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min
arm group label: crystalloids
arm group type: No Intervention
description: Patients received intravenously saline solution at 10 ml/Kg/h
intervention type: Drug
intervention name: Dopamine
arm group label: dopamine
other name: Revivan
criteria: 
gender: Female
minimum age: 24 Years
maximum age: 42 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Francesca Bevilacqua
investigator title: Medical Doctor
mesh term: Dopamine