<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/NCT03778944</url>
  </required_header>
  <id_info>
    <org_study_id>RGFEDDA</org_study_id>
    <nct_id>NCT03778944</nct_id>
  </id_info>
  <brief_title>Enhancing Renal Graft Function During Donor Anesthesia</brief_title>
  <official_title>Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nazmy Edward Seif</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Renal transplantation is now recognized as the treatment of choice for patients with&#xD;
      end-stage renal disease. An optimum anesthetic regimen should enhance the function and&#xD;
      perfusion of the transplanted kidney. The aim of this study is to assess &amp; compare the&#xD;
      effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate&#xD;
      hydration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>
    <intervention_model_description>Using computer &amp; sealed envelope randomization, patients are assigned to receive either Mannitol [M group; n=20], Dopamine [D group; n=20] or adequate hydration [C group; n=20]</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative creatinine clearance</measure>
    <time_frame>7 days</time_frame>
    <description>Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Renal Failure Chronic</condition>
  <condition>Transplant;Failure,Kidney</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>M group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mannitol infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dopamine infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adequate hydration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mannitol infusion</intervention_name>
    <description>Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.</description>
    <arm_group_label>M group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dopamine infusion</intervention_name>
    <description>Infusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery.</description>
    <arm_group_label>D group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adequate hydration</intervention_name>
    <description>Infusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery.</description>
    <arm_group_label>C group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  end-stage renal disease, for living-donor kidney transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cardiac or hepatic dysfunction&#xD;
&#xD;
          -  coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazmy E Seif, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kasr Al-Ainy Hospital, Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed M Elbadawy, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kasr Al-Ainy Hospital, Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nazmy E Seif, MD</last_name>
    <phone>01227400808</phone>
    <phone_ext>+2</phone_ext>
    <email>drnazmyseif@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed M Elbadawy, MD</last_name>
    <phone>01064249076</phone>
    <phone_ext>+2</phone_ext>
    <email>elbadawyahmed89@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Al-Ainy Hospital, Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nazmy E Seif, MD</last_name>
      <phone>01227400808</phone>
      <phone_ext>+2</phone_ext>
      <email>drnazmyseif@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed M Elbadawy, MD</last_name>
      <phone>01064249076</phone>
      <phone_ext>+2</phone_ext>
      <email>elbadawyahmed89@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nazmy Edward Seif</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Mannitol</keyword>
  <keyword>Dopamine</keyword>
  <keyword>Perfusion</keyword>
  <keyword>Renal graft donor</keyword>
  <keyword>Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Mannitol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03778944
org study id: RGFEDDA
nct id: NCT03778944
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Renal transplantation is now recognized as the treatment of choice for patients with
      end-stage renal disease. An optimum anesthetic regimen should enhance the function and
      perfusion of the transplanted kidney. The aim of this study is to assess & compare the
      effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate
      hydration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Using computer & sealed envelope randomization, patients are assigned to receive either Mannitol [M group; n=20], Dopamine [D group; n=20] or adequate hydration [C group; n=20]
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Post-operative creatinine clearance
time frame: 7 days
description: Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min
arm group label: M group
arm group type: Active Comparator
description: Mannitol infusion
arm group label: D group
arm group type: Active Comparator
description: Dopamine infusion
arm group label: C group
arm group type: Active Comparator
description: Adequate hydration
intervention type: Procedure
intervention name: Mannitol infusion
description: Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.
arm group label: M group
intervention type: Procedure
intervention name: Dopamine infusion
description: Infusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery.
arm group label: D group
intervention type: Procedure
intervention name: Adequate hydration
description: Infusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery.
arm group label: C group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Nazmy E Seif, MD
role: Study Chair
affiliation: Kasr Al-Ainy Hospital, Cairo University
last name: Ahmed M Elbadawy, MD
role: Study Director
affiliation: Kasr Al-Ainy Hospital, Cairo University
last name: Nazmy E Seif, MD
phone: 01227400808
phone ext: +2
email: drnazmyseif@yahoo.com
last name: Ahmed M Elbadawy, MD
phone: 01064249076
phone ext: +2
email: elbadawyahmed89@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Nazmy Edward Seif
investigator title: Clinical Professor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Dopamine
mesh term: Mannitol
sharing ipd: Undecided