<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/NCT03306914</url>
  </required_header>
  <id_info>
    <org_study_id>Albumin versus starch</org_study_id>
    <nct_id>NCT03306914</nct_id>
  </id_info>
  <brief_title>Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients</brief_title>
  <official_title>Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</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>
      In this study we try to review the possible effects when using modern hydroxyethylstarch&#xD;
      solutions 6 % versus albumin 5% during living donor renal transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of complications</measure>
    <time_frame>7 days</time_frame>
    <description>Increased creatinine and/or need for dialysis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Anesthesia Morbidity</condition>
  <arm_group>
    <arm_group_label>Albumin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Albumin resuscitation Albumin 5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydroxyethylstarch group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydroxyethylstarch resuscitation Hydroxyethylstarch 6%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Albumin resuscitation</intervention_name>
    <description>Albumin 5% is used as the intra-operative colloid</description>
    <arm_group_label>Albumin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydroxyethylstarch resuscitation</intervention_name>
    <description>Hydroxyethyl starch 6% is used as the intra-operative colloid</description>
    <arm_group_label>Hydroxyethylstarch group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin 5%</intervention_name>
    <description>Infusion of Albumin 5% intra-operatively</description>
    <arm_group_label>Albumin group</arm_group_label>
    <other_name>Albumin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxyethylstarch 6%</intervention_name>
    <description>Infusion of Hydroxyethylstarch 6% intra-operatively</description>
    <arm_group_label>Hydroxyethylstarch group</arm_group_label>
    <other_name>Tetraspan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  end stage renal disease, for living donor renal transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cardiac or hepatic dysfunction, re-transplantation, 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>Ahmed Kareem</last_name>
    <role>Study Director</role>
    <affiliation>Kasr Al-Ainy Hospiral, Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Kareem</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxyethyl Starch Derivatives</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03306914
org study id: Albumin versus starch
nct id: NCT03306914
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study we try to review the possible effects when using modern hydroxyethylstarch
      solutions 6 % versus albumin 5% during living donor renal transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Occurrence of complications
time frame: 7 days
description: Increased creatinine and/or need for dialysis
arm group label: Albumin group
arm group type: Active Comparator
description: Albumin resuscitation Albumin 5%
arm group label: Hydroxyethylstarch group
arm group type: Experimental
description: Hydroxyethylstarch resuscitation Hydroxyethylstarch 6%
intervention type: Other
intervention name: Albumin resuscitation
description: Albumin 5% is used as the intra-operative colloid
arm group label: Albumin group
intervention type: Other
intervention name: Hydroxyethylstarch resuscitation
description: Hydroxyethyl starch 6% is used as the intra-operative colloid
arm group label: Hydroxyethylstarch group
intervention type: Drug
intervention name: Albumin 5%
description: Infusion of Albumin 5% intra-operatively
arm group label: Albumin group
other name: Albumin
intervention type: Drug
intervention name: Hydroxyethylstarch 6%
description: Infusion of Hydroxyethylstarch 6% intra-operatively
arm group label: Hydroxyethylstarch group
other name: Tetraspan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed Kareem
role: Study Director
affiliation: Kasr Al-Ainy Hospiral, Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Kareem
investigator title: Principal Investigator
mesh term: Hydroxyethyl Starch Derivatives
sharing ipd: No