<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/NCT01708759</url>
  </required_header>
  <id_info>
    <org_study_id>1380/09/12</org_study_id>
    <nct_id>NCT01708759</nct_id>
  </id_info>
  <brief_title>IL8 Monitoring and Its Correlation With 251-gene Polymorphism</brief_title>
  <official_title>The Value of Admission Serum Il-8 Monitoring and the Detection of IL8 (-251 A/T) Polymorphism in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One hundred eighty critically ill African adult intensive care patients divided into two&#xD;
      groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic&#xD;
      critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and&#xD;
      SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of one hundred eighty African patients (97men and 83 women) were included in the&#xD;
      study. Eighty patients developed septic complication during ICU stay (sepsis group). Eighty&#xD;
      patients were critically ill without evidence of infectious organism (SIRS group). Patients&#xD;
      received anti-inflammatory drugs or corticosteroids before admission, who had&#xD;
      immunosuppressive illness, who had chronic organ failure; who had received massive blood&#xD;
      transfusion; those with radiation therapy, previous organ transplantation were excluded from&#xD;
      the study. At admission, the patient's age, sex, height and weight were recorded. These data&#xD;
      include the following: clinical status; sequential organ failure assessment (SOFA) score;&#xD;
      temperature; heart rate; respiratory rate; blood pressure; central venous pressure;&#xD;
      laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium,&#xD;
      potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time,&#xD;
      albumin and CRP) and arterial blood gas analysis. Routine cultures of blood, urine and&#xD;
      suspected sites were obtained to determine the presence of infection. We attempted to&#xD;
      maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o.&#xD;
      If needed, blood products, intravascular fluid replacement and inotropic and/or vasopressor&#xD;
      agents were administered. Each day the attending physician in the ICU evaluated all the study&#xD;
      patients for sepsis, severe sepsis, or septic shock.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Interlukin-8</measure>
    <time_frame>At intensive care admission. Patients will be followed for at least 2 weeks</time_frame>
    <description>Serum level of IL-8 was determined by quantitative sandwich enzyme immunoassay (R&amp;D Systems, Inc., Minneapolis, MN, USA) according to the manufacturer's instructions. The intensity of the colour was measured at 490 nm for IL-8.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interlukine-8polymorphism at 251 A/t</measure>
    <time_frame>At ICU admission. Patients will be followed for at least 2weeks.</time_frame>
    <description>About 4ml blood is withdrawn in EDTA-tubes and the genomic DNA was extracted. Concentration of the extracted DNA was then measured by UV spectrophotometry at 260&amp; 280 nm and run on agaros gel electrophoresis 2% for detection of purity. Molecular detection of the (-251 A/T) polymorphism in the IL-8gene was achieved by restriction fragment length polymorphism typing.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Sepsis</condition>
  <condition>Systemic Inflammatory Response Syndrome</condition>
  <arm_group>
    <arm_group_label>Sepsis</arm_group_label>
    <description>Forty patients developed septic complication during ICU stay (sepsis group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIRS</arm_group_label>
    <description>Forty patients were critically ill without evidence of infectious organism (SIRS group).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of eighty African patients (47men and 33 women) were included in the study. Forty&#xD;
        patients developed septic complication during ICU stay (sepsis group). Forty patients were&#xD;
        critically ill without evidence of infectious organism (SIRS group).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults patients with clinical diagnosis of sepsis or systemic inflammatory response&#xD;
        syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients received anti-inflammatory drugs or corticosteroids before admission, patients who&#xD;
        had immunosuppressive illness ie. AIDS, patients with chronic liver failure, patients with&#xD;
        renal failure, patients with respiratory failure ; patients received massive blood&#xD;
        transfusion; patients with radiation therapy, patients with organ transplantation .&#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>Ayman A Yousef, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine ,Tanta University.</name>
      <address>
        <city>Tanta</city>
        <state>Algharbiya</state>
        <zip>35217</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Gyulai Z, Klausz G, Tiszai A, Lenart Z, Kasa IT, Lonovics J, Mandi Y. Genetic polymorphism of interleukin-8 (IL-8) is associated with Helicobacter pylori-induced duodenal ulcer. Eur Cytokine Netw. 2004 Oct-Dec;15(4):353-8.</citation>
    <PMID>15627645</PMID>
  </reference>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>April 6, 2014</last_update_submitted>
  <last_update_submitted_qc>April 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Ayman Abd Al-maksoud Yousef</investigator_full_name>
    <investigator_title>Assistant professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Serum Il-8</keyword>
  <keyword>IL8 polymorphism</keyword>
  <keyword>critically ill patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Systemic Inflammatory Response Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT01708759
org study id: 1380/09/12
nct id: NCT01708759
lead sponsor: 
has dmc: Yes
One hundred eighty critically ill African adult intensive care patients divided into two
      groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic
      critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and
      SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.
A total of one hundred eighty African patients (97men and 83 women) were included in the
      study. Eighty patients developed septic complication during ICU stay (sepsis group). Eighty
      patients were critically ill without evidence of infectious organism (SIRS group). Patients
      received anti-inflammatory drugs or corticosteroids before admission, who had
      immunosuppressive illness, who had chronic organ failure; who had received massive blood
      transfusion; those with radiation therapy, previous organ transplantation were excluded from
      the study. At admission, the patient's age, sex, height and weight were recorded. These data
      include the following: clinical status; sequential organ failure assessment (SOFA) score;
      temperature; heart rate; respiratory rate; blood pressure; central venous pressure;
      laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium,
      potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time,
      albumin and CRP) and arterial blood gas analysis. Routine cultures of blood, urine and
      suspected sites were obtained to determine the presence of infection. We attempted to
      maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o.
      If needed, blood products, intravascular fluid replacement and inotropic and/or vasopressor
      agents were administered. Each day the attending physician in the ICU evaluated all the study
      patients for sepsis, severe sepsis, or septic shock.
observational model: Case-Control
time perspective: Prospective
measure: Serum Interlukin-8
time frame: At intensive care admission. Patients will be followed for at least 2 weeks
description: Serum level of IL-8 was determined by quantitative sandwich enzyme immunoassay (R&D Systems, Inc., Minneapolis, MN, USA) according to the manufacturer's instructions. The intensity of the colour was measured at 490 nm for IL-8.
measure: Interlukine-8polymorphism at 251 A/t
time frame: At ICU admission. Patients will be followed for at least 2weeks.
description: About 4ml blood is withdrawn in EDTA-tubes and the genomic DNA was extracted. Concentration of the extracted DNA was then measured by UV spectrophotometry at 260& 280 nm and run on agaros gel electrophoresis 2% for detection of purity. Molecular detection of the (-251 A/T) polymorphism in the IL-8gene was achieved by restriction fragment length polymorphism typing.
arm group label: Sepsis
description: Forty patients developed septic complication during ICU stay (sepsis group).
arm group label: SIRS
description: Forty patients were critically ill without evidence of infectious organism (SIRS group).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ayman A Yousef, MD
role: Principal Investigator
affiliation: Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
facility: 
country: Egypt
citation: Gyulai Z, Klausz G, Tiszai A, Lenart Z, Kasa IT, Lonovics J, Mandi Y. Genetic polymorphism of interleukin-8 (IL-8) is associated with Helicobacter pylori-induced duodenal ulcer. Eur Cytokine Netw. 2004 Oct-Dec;15(4):353-8.
PMID: 15627645
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Ayman Abd Al-maksoud Yousef
investigator title: Assistant professor of Anesthesiology
mesh term: Systemic Inflammatory Response Syndrome