<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/NCT03039777</url>
  </required_header>
  <id_info>
    <org_study_id>17a1b</org_study_id>
    <nct_id>NCT03039777</nct_id>
  </id_info>
  <brief_title>Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients</brief_title>
  <official_title>Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New Jeddah Clinic Hospital</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Benha University</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>
      Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI).&#xD;
      Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its&#xD;
      role as a surrogacy marker in CRBSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically,&#xD;
      fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated&#xD;
      c-reactive protein level are considered as markers for CRBSI before blood culture results&#xD;
      became available.&#xD;
&#xD;
      Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be&#xD;
      measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI&#xD;
      by blood cultures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Procalcitonin Level</measure>
    <time_frame>2 minutes after start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>Level of serum procalcitonin</description>
  </primary_outcome>
  <other_outcome>
    <measure>Blood culture (central and peripheral) results</measure>
    <time_frame>5 minutes after start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>Blood cultures organism growth results (positive/negative) confirming CRBSI</description>
  </other_outcome>
  <other_outcome>
    <measure>C Reactive Protein</measure>
    <time_frame>2 minutes after start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>Level of C reactive protein</description>
  </other_outcome>
  <other_outcome>
    <measure>erythrocyte sedimentation rate</measure>
    <time_frame>2 minutes after start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>erythrocyte sedimentation rate</description>
  </other_outcome>
  <other_outcome>
    <measure>Urea Reduction Rate</measure>
    <time_frame>up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>Urea Reduction rate</description>
  </other_outcome>
  <other_outcome>
    <measure>creatinine</measure>
    <time_frame>up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>predialysis Serum creatinine</description>
  </other_outcome>
  <other_outcome>
    <measure>ferritin</measure>
    <time_frame>up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>predialysis Serum ferritin</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>Hemoglobin</description>
  </other_outcome>
  <other_outcome>
    <measure>potassium</measure>
    <time_frame>up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>predialysis serum potassium</description>
  </other_outcome>
  <other_outcome>
    <measure>Sodium</measure>
    <time_frame>up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI</time_frame>
    <description>predialysis serum sodium</description>
  </other_outcome>
  <enrollment type="Actual">28</enrollment>
  <condition>Hemodialysis Catheter Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hemodialysis patients with clinical signs of CRBSI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemodialysis patients with a dialysis catheter&#xD;
&#xD;
          -  signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of&#xD;
             infection.&#xD;
&#xD;
          -  Informed consent signed to be enrolled in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with identified cause of fever other than CRBSI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud H Imam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benha University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New jeddah clinic Hospital</name>
      <address>
        <city>Jeddah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>July 13, 2017</last_update_submitted>
  <last_update_submitted_qc>July 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Mahmoud Hamada imam</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
  </condition_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/NCT03039777
org study id: 17a1b
nct id: NCT03039777
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI).
      Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its
      role as a surrogacy marker in CRBSI.
Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically,
      fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated
      c-reactive protein level are considered as markers for CRBSI before blood culture results
      became available.

      Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be
      measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI
      by blood cultures.
observational model: Cohort
time perspective: Prospective
measure: Procalcitonin Level
time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
description: Level of serum procalcitonin
measure: Blood culture (central and peripheral) results
time frame: 5 minutes after start of fever/chills or other symptoms suggesting CRBSI
description: Blood cultures organism growth results (positive/negative) confirming CRBSI
measure: C Reactive Protein
time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
description: Level of C reactive protein
measure: erythrocyte sedimentation rate
time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
description: erythrocyte sedimentation rate
measure: Urea Reduction Rate
time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
description: Urea Reduction rate
measure: creatinine
time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
description: predialysis Serum creatinine
measure: ferritin
time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
description: predialysis Serum ferritin
measure: Hemoglobin
time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
description: Hemoglobin
measure: potassium
time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
description: predialysis serum potassium
measure: Sodium
time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
description: predialysis serum sodium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mahmoud H Imam, MD
role: Principal Investigator
affiliation: Benha University
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Mahmoud Hamada imam
investigator title: Dr.
mesh term: Bacteremia
sharing ipd: No