<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/NCT03230214</url>
  </required_header>
  <id_info>
    <org_study_id>020583</org_study_id>
    <nct_id>NCT03230214</nct_id>
  </id_info>
  <brief_title>Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During Liver Transplantation</brief_title>
  <official_title>Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During a Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <brief_summary>
    <textblock>
      The present study is to demonstrate the effect of the presence of bacterial translocation&#xD;
      detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the&#xD;
      polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a&#xD;
      liver transplant procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">November 14, 2017</completion_date>
  <primary_completion_date type="Actual">October 24, 2017</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 the mean arterial blood pressure</measure>
    <time_frame>at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>antifactor X activity</measure>
    <time_frame>at the beginning of surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in the heart rate</measure>
    <time_frame>at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in the cardiac output</measure>
    <time_frame>at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Effect of Bacterial Translocation</condition>
  <arm_group>
    <arm_group_label>DNA positive patients</arm_group_label>
    <description>patients who have bacterial DNA in their samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DNA negative patients</arm_group_label>
    <description>patients who do not have bacterial DNA in their samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PCR for bacterial translocation</intervention_name>
    <description>samples taken from the blood and ascites of patients to search for bacterial DNA</description>
    <arm_group_label>DNA negative patients</arm_group_label>
    <arm_group_label>DNA positive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients with grade C liver cirrhosis with liver failure undergoing liver&#xD;
        transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • patients with liver failure undergoing liver transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years;&#xD;
&#xD;
          -  Active overt infection;&#xD;
&#xD;
          -  Patients on oral or systemic anticoagulation or with known coagulopathic disorders&#xD;
             apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital&#xD;
             platelet disorders and congenital coagulation disorders…etc);&#xD;
&#xD;
          -  Patients undergoing re-transplantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>ahmed mukhtar, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elmoasah Hospital</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>January 13, 2018</last_update_submitted>
  <last_update_submitted_qc>January 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Heba Moharem</investigator_full_name>
    <investigator_title>assisstant lecturer</investigator_title>
  </responsible_party>
  <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/NCT03230214
org study id: 020583
nct id: NCT03230214
lead sponsor: 
The present study is to demonstrate the effect of the presence of bacterial translocation
      detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the
      polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a
      liver transplant procedure.
observational model: Cohort
time perspective: Prospective
measure: change in the mean arterial blood pressure
time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
measure: antifactor X activity
time frame: at the beginning of surgery
measure: change in the heart rate
time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
measure: change in the cardiac output
time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
arm group label: DNA positive patients
description: patients who have bacterial DNA in their samples
arm group label: DNA negative patients
description: patients who do not have bacterial DNA in their samples
intervention type: Diagnostic Test
intervention name: PCR for bacterial translocation
description: samples taken from the blood and ascites of patients to search for bacterial DNA
arm group label: DNA negative patients
arm group label: DNA positive patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
last name: ahmed mukhtar, MD
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Heba Moharem
investigator title: assisstant lecturer
sharing ipd: Undecided