<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/NCT01708772</url>
  </required_header>
  <id_info>
    <org_study_id>1381/09/12</org_study_id>
    <nct_id>NCT01708772</nct_id>
  </id_info>
  <brief_title>Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients</brief_title>
  <official_title>The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring 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>
      A total of ninety patients (52men and 38women) were included in the study. Forty five&#xD;
      patients developed septic complication during ICU stay (sepsis group). Forty five patients&#xD;
      were critically ill without evidence of infectious organism (SIRS group). At admission,&#xD;
      Patients data include clinical status; SOFA score; central venous pressure; laboratory&#xD;
      analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The&#xD;
      attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long&#xD;
      as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients staying in ICU for more than 24 hours were enrolled in the study. Patients&#xD;
      received anti-inflammatory drugs or corticosteroids before admission, patients had&#xD;
      immunosuppressive illness, patients had chronic organ failure; patients received massive&#xD;
      blood transfusion; patients with radiation therapy and patients with previous organ&#xD;
      transplantation were excluded from the study. At admission, patient's age, sex, weight and&#xD;
      height were recorded. Patients data that include the clinical status; sequential organ&#xD;
      failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure;&#xD;
      central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen,&#xD;
      blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine&#xD;
      aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were&#xD;
      measured. Routine cultures of suspected sites, blood and urine were obtained to determine the&#xD;
      presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and&#xD;
      central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood&#xD;
      products and inotropic or vasopressor agents were administered. Each day the attending&#xD;
      physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long&#xD;
      as their stay in ICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>TNF-a determination using ELISA.</measure>
    <time_frame>Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.</time_frame>
    <description>A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R&amp;D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of SOFA score:</measure>
    <time_frame>Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks.</time_frame>
    <description>SOFA score is composed of scores of six organ systems (respiratory [R], cardiovascular [C], hepatic [H], coagulation [Co], renal [Re], and neurological [N]) graded from 0 to 4 according to the degree of dysfunction/ failure.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Sepsis</condition>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>Sepsis</arm_group_label>
    <description>Forty five patients developed septic complication during ICU stay (sepsis group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIRS group</arm_group_label>
    <description>Forty five patients were critically ill without evidence of infectious organism (SIRS group).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of ninety patients (52men and 38women) were included in the study. Forty five&#xD;
        patients developed septic complication during ICU stay (sepsis group). Forty five patients&#xD;
        were critically ill without evidence of infectious organism (SIRS group). Patients were&#xD;
        classified into their groups at the time of the first blood analysis for these biomarkers&#xD;
        at ICU admission.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients staying in ICU for more than 24 hours were enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The Patients received anti-inflammatory drugs or corticosteroids before admission,&#xD;
             patients had immunosuppressive illness, patients had chronic organ failure;&#xD;
&#xD;
          -  Patients received massive blood transfusion;&#xD;
&#xD;
          -  Patients with radiation therapy and patients with previous organ transplantation were&#xD;
             excluded from the study.&#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>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>Ferrerira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001:286(14):1754-1758. Sheeran P, Hall GM. Cytokine balance and immunosuppressive changes at cardiac surgery. Br J Anaesth 1996; 77: 129-30. Robertshaw H J, Brennan F M. Release of tumour necrosis factor a (TNF-a) by TNF a cleaving enzyme (TACE) in response to septic stimuli in vitro. Br J Anaesth 2005; 94: 222-8.</citation>
  </reference>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 10, 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>June 6, 2013</last_update_submitted>
  <last_update_submitted_qc>June 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 7, 2013</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 Anesthesia</investigator_title>
  </responsible_party>
  <keyword>TNF alpha</keyword>
  <keyword>SOFA score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT01708772
org study id: 1381/09/12
nct id: NCT01708772
lead sponsor: 
has dmc: Yes
A total of ninety patients (52men and 38women) were included in the study. Forty five
      patients developed septic complication during ICU stay (sepsis group). Forty five patients
      were critically ill without evidence of infectious organism (SIRS group). At admission,
      Patients data include clinical status; SOFA score; central venous pressure; laboratory
      analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The
      attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long
      as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.
The patients staying in ICU for more than 24 hours were enrolled in the study. Patients
      received anti-inflammatory drugs or corticosteroids before admission, patients had
      immunosuppressive illness, patients had chronic organ failure; patients received massive
      blood transfusion; patients with radiation therapy and patients with previous organ
      transplantation were excluded from the study. At admission, patient's age, sex, weight and
      height were recorded. Patients data that include the 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 were
      measured. Routine cultures of suspected sites, blood and urine 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. When needed, intravascular fluid replacement, blood
      products and inotropic or vasopressor agents were administered. Each day the attending
      physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long
      as their stay in ICU.
observational model: Case-Control
time perspective: Prospective
measure: TNF-a determination using ELISA.
time frame: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
description: A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm.
measure: Evaluation of SOFA score:
time frame: Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
description: SOFA score is composed of scores of six organ systems (respiratory [R], cardiovascular [C], hepatic [H], coagulation [Co], renal [Re], and neurological [N]) graded from 0 to 4 according to the degree of dysfunction/ failure.
arm group label: Sepsis
description: Forty five patients developed septic complication during ICU stay (sepsis group).
arm group label: SIRS group
description: Forty five 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: Ferrerira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001:286(14):1754-1758. Sheeran P, Hall GM. Cytokine balance and immunosuppressive changes at cardiac surgery. Br J Anaesth 1996; 77: 129-30. Robertshaw H J, Brennan F M. Release of tumour necrosis factor a (TNF-a) by TNF a cleaving enzyme (TACE) in response to septic stimuli in vitro. Br J Anaesth 2005; 94: 222-8.
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Ayman Abd Al-maksoud Yousef
investigator title: Assistant Professor of Anesthesia
mesh term: Critical Illness