<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/NCT03776396</url>
  </required_header>
  <id_info>
    <org_study_id>31/2016/PO</org_study_id>
    <nct_id>NCT03776396</nct_id>
  </id_info>
  <brief_title>Perioperative Goal Directed Therapy in Kidney Transplantation</brief_title>
  <official_title>Perioperative Protocol Goal Directed Therapy in Kidney Transplantation: Fluid Therapy Optimization and Impact on Postoperative Complications.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Catania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Catania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In literature there is a huge amount of works demonstrating the direct correlation between&#xD;
      volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major&#xD;
      postoperative complications in patients with high cardiovascular risk and chronic renal&#xD;
      failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that&#xD;
      in certain populations with high surgical and post-operative complications risk, the adoption&#xD;
      of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The&#xD;
      current trend is therefore to guarantee greater precision in the intraoperative management of&#xD;
      patients undergoing kidney transplantation from cadaver by using a specific protocol that can&#xD;
      be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT),&#xD;
      resulting from the adoption of an advanced minimally invasive hemodynamic monitoring&#xD;
      technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively&#xD;
      tested in an extensive case series of high perioperative risk patients underwent to major&#xD;
      abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic&#xD;
      surgery. In the present study there will be enrolled all patients who are candidates for&#xD;
      kidney transplant from cadaver at the University Hospital &quot;G. Rodolico&quot; of Catania that meet&#xD;
      the inclusion criteria of the study and will give their informed consent to participation.&#xD;
      The enrolled patients will be monitored for a maximum period of 7 days from transplantation.&#xD;
      As control group there will be considered an historical cohort of patients who underwent&#xD;
      kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a&#xD;
      common hemodynamic monitoring, based on parameters such as central venous pressure and / or&#xD;
      invasive arterial pressure, was performed according to the international guidelines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2016</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 19, 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>Frequency rate of postoperative complications</measure>
    <time_frame>7 days after transplantation</time_frame>
    <description>The frequency rate of the subsequent postoperative complications in the two study cohort will be determined: early postoperative pulmonary complications (prolonged mechanical ventilation, failure acute respiratory disease, acute pulmonary edema, pulmonary infections); major cardiovascular complications (ischemic cardiac events and heart failure congestive); major surgical complications (anastomosis, delayed postoperative ileum, nausea and postoperative vomiting).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of hospitalization in a semi-intensive and intensive hospital ward.</measure>
    <time_frame>7 days after transplantation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with delayed graft failure in the two study cohorts</measure>
    <time_frame>7 days after transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring hemodialysis in the two study cohorts</measure>
    <time_frame>7 days after transplantation</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Experimental cohort</arm_group_label>
    <description>33 patient undergoing to kidney transplantation from cadaver at University Hospital &quot;G. Rodolico&quot; of Catania, in which an innovative Perioperative Goal Directed Therapy (PGDT) protocol will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical control group</arm_group_label>
    <description>33 patients underwent to kidney transplantation from cadaver at University Hospital &quot;G. Rodolico&quot; of Catania in 2015, in which a PGDT protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        33 consecutive patients candidates for kidney transplantation from cadaver that meet the&#xD;
        eligibility criteria of the study and 33 patients who underwent kidney transplantation in&#xD;
        2015&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Classification III-IV;&#xD;
&#xD;
          -  Age between 18 and 65 years;&#xD;
&#xD;
          -  First kidney transplantation from cadaver;&#xD;
&#xD;
          -  Absence of atrial fibrillation or severe arrhythmia;&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent;&#xD;
&#xD;
          -  Age less that 18 or greater than 65 years;&#xD;
&#xD;
          -  Atrial fibrillation and high frequency tachyarrhythmias;&#xD;
&#xD;
          -  Previous transplantation from cadaver.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>&quot;G. Rodolico&quot; Presidium of the Azienda Ospedaliero Universitaria &quot;Policlinico-Vittorio Emanuele&quot;</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Catania</investigator_affiliation>
    <investigator_full_name>Marinella Astuto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Perioperative Goal Directed Therapy</keyword>
  <keyword>Minimally invasive hemodynamic monitoring</keyword>
  <keyword>Kidney transplantation</keyword>
  <!-- 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/NCT03776396
org study id: 31/2016/PO
nct id: NCT03776396
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In literature there is a huge amount of works demonstrating the direct correlation between
      volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major
      postoperative complications in patients with high cardiovascular risk and chronic renal
      failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that
      in certain populations with high surgical and post-operative complications risk, the adoption
      of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The
      current trend is therefore to guarantee greater precision in the intraoperative management of
      patients undergoing kidney transplantation from cadaver by using a specific protocol that can
      be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT),
      resulting from the adoption of an advanced minimally invasive hemodynamic monitoring
      technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively
      tested in an extensive case series of high perioperative risk patients underwent to major
      abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic
      surgery. In the present study there will be enrolled all patients who are candidates for
      kidney transplant from cadaver at the University Hospital "G. Rodolico" of Catania that meet
      the inclusion criteria of the study and will give their informed consent to participation.
      The enrolled patients will be monitored for a maximum period of 7 days from transplantation.
      As control group there will be considered an historical cohort of patients who underwent
      kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a
      common hemodynamic monitoring, based on parameters such as central venous pressure and / or
      invasive arterial pressure, was performed according to the international guidelines.
observational model: Cohort
time perspective: Prospective
measure: Frequency rate of postoperative complications
time frame: 7 days after transplantation
description: The frequency rate of the subsequent postoperative complications in the two study cohort will be determined: early postoperative pulmonary complications (prolonged mechanical ventilation, failure acute respiratory disease, acute pulmonary edema, pulmonary infections); major cardiovascular complications (ischemic cardiac events and heart failure congestive); major surgical complications (anastomosis, delayed postoperative ileum, nausea and postoperative vomiting).
measure: Duration of hospitalization in a semi-intensive and intensive hospital ward.
time frame: 7 days after transplantation
measure: Number of patients with delayed graft failure in the two study cohorts
time frame: 7 days after transplantation
measure: Number of patients requiring hemodialysis in the two study cohorts
time frame: 7 days after transplantation
arm group label: Experimental cohort
description: 33 patient undergoing to kidney transplantation from cadaver at University Hospital "G. Rodolico" of Catania, in which an innovative Perioperative Goal Directed Therapy (PGDT) protocol will be used.
arm group label: Historical control group
description: 33 patients underwent to kidney transplantation from cadaver at University Hospital "G. Rodolico" of Catania in 2015, in which a PGDT protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Catania
investigator full name: Marinella Astuto
investigator title: Principal Investigator