<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/NCT04431492</url>
  </required_header>
  <id_info>
    <org_study_id>13700418</org_study_id>
    <nct_id>NCT04431492</nct_id>
  </id_info>
  <brief_title>Effect of Anaesthesia on Basic Aminoacids</brief_title>
  <official_title>Effect of Anaesthesia and Surgery on Plasma Levels of Nitric Oxide and Basic Aminoacids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Basic amino acids are acids that contains amino groups more than carboxylic groups. At least&#xD;
      five basic amino acids namely; Arginine, citrulline, ornithine, lysine and hydroxylysine&#xD;
      metabolize in our body. Loss of body protein represents a typical feature of the catabolic&#xD;
      response to surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">December 2, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>basic aminoacids and NO levels</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Effect of Anaesthesia on Basic Aminoacids</condition>
  <arm_group>
    <arm_group_label>coronary artery bypass</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>thoracic surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CABG</intervention_name>
    <description>aminoacids and NO levels</description>
    <arm_group_label>coronary artery bypass</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing cardiopulmonary bypass and thoracotomy for lung resection secondary to&#xD;
        lung carcinoma, three samples will be taken to evaluate the levels of basic amino acids and&#xD;
        NO levels&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
          -  ASA II,III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Associated renal or liver disease&#xD;
&#xD;
          -  Chronic disease as D.M&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>saeid elsawy</last_name>
    <phone>01030072161</phone>
    <email>saeedelsawy17@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ali</last_name>
    <phone>01030072161</phone>
    <email>rashaahmed7272@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>rasha hamed, MD</last_name>
      <phone>0882413201</phone>
      <email>rashaahmed11@yahoo.nom</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Rasha Hamed</investigator_full_name>
    <investigator_title>lecturer of anaesthesia</investigator_title>
  </responsible_party>
  <!-- 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/NCT04431492
org study id: 13700418
nct id: NCT04431492
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Basic amino acids are acids that contains amino groups more than carboxylic groups. At least
      five basic amino acids namely; Arginine, citrulline, ornithine, lysine and hydroxylysine
      metabolize in our body. Loss of body protein represents a typical feature of the catabolic
      response to surgery.
observational model: Case-Only
time perspective: Prospective
measure: basic aminoacids and NO levels
time frame: 72 hours
arm group label: coronary artery bypass
arm group label: thoracic surgery
intervention type: Procedure
intervention name: CABG
description: aminoacids and NO levels
arm group label: coronary artery bypass
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
last name: saeid elsawy
phone: 01030072161
email: saeedelsawy17@gmail.com
last name: Ali
phone: 01030072161
email: rashaahmed7272@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Rasha Hamed
investigator title: lecturer of anaesthesia