<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/NCT02259439</url>
  </required_header>
  <id_info>
    <org_study_id>16022012</org_study_id>
    <nct_id>NCT02259439</nct_id>
  </id_info>
  <brief_title>Assessment of Updated Evaluation Scores in Critically ILL COPD Patients Admitted to Assiut University Hospital</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nermeen Aly Mahmoud Abdel Aleem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading&#xD;
      cause of morbidity and mortality.Patients admitted to hospital present higher mortality&#xD;
      rates.The investigators lack the specific tools that allow us to easily classify and&#xD;
      establish the individual prognosis for each patient during their hospitalization.&#xD;
&#xD;
      Rational of the study:to identify the predictive factors for hospital mortality in critically&#xD;
      ill patients admitted to hospital due to an episode of COPD exacerbation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material and Methods:&#xD;
&#xD;
      A) sociodemographic variables:&#xD;
&#xD;
      Age, sex, marital status, occupation, pack\year.&#xD;
&#xD;
      B) clinical variables:&#xD;
&#xD;
      1- Dyspnea measured by the Medical Research Council (MRC) scale and the COPD Assessment Test&#xD;
      (CAT ) while stable, previous to admittance.&#xD;
&#xD;
      3- Charlson comorbidity index and age adjusted model.&#xD;
&#xD;
      4- The APACHE II scale: the severity of the episode upon admittance, calculated using the&#xD;
      APACHE II scale, using the worst value obtained in the first 24h after being admitted to&#xD;
      hospital.&#xD;
&#xD;
      5- the Sequential Organ Failure Assessment (SOFA) scale.&#xD;
&#xD;
      6- Lab parameters: such as glucose, albumin and heamatocrit&#xD;
&#xD;
      7- BAP-65 score: elevated blood urea nitrogen, altered mental status, pulse &gt; 109 beats/min,&#xD;
      age &gt; 65 years.&#xD;
&#xD;
      8- Assessment of symptom of gastroesophageal reflux disease.&#xD;
&#xD;
      9-Glasgow scale score.&#xD;
&#xD;
      10-CURB 65 :&quot;C&quot; stands for &quot;confused&quot;; &quot;U&quot; stands for BUN greater than19 mg/dL; &quot;R&quot; stands&#xD;
      for &quot;respiration more than 30 breaths per minute&quot;&quot;B&quot; stands for blood pressure less than 90&#xD;
      mm Hg systolic or diastolic blood pressure 60 mm Hg or less; &quot;65&quot; stands ≥65 years.&#xD;
&#xD;
      11-CAUDA 70: C: Confusion, Acidosis (pH &lt;7.35), Urea &gt;7mmol/L, MRC Dyspnoea score &gt;4, Albumin&#xD;
      &lt;35g/L, Age &gt;70 years. One point was assigned to each variable present, giving a six point&#xD;
      scoring system.&#xD;
&#xD;
      12-The COPD and Asthma Physiology Score.&#xD;
&#xD;
      13-The early warning score.&#xD;
&#xD;
      14-ADO index: comprised of age, dyspnea by the MRC, and FEV1. Scores ranged from 0 (best&#xD;
      status) to 5 (worst status) for age, 0-3 for MRC, and 0-2 for FEV1. Points for each component&#xD;
      were added so that the ADO index ranged from 0 to 10.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Calculate the mortality of exacerbated patients based on APACHE II and SOFA score, respiratory rate upon admittance, age, pO2/ FiO2 in the first few hours of admittance.</measure>
    <time_frame>24 hours</time_frame>
    <description>Calculate mortality caused by AECOPD depend upon APACHE II and SOFA score</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We include for study all patients critically ill hospitalized for COPD exacerbation during&#xD;
        the study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  We include for study all patients critically ill hospitalized for COPD exacerbation&#xD;
             during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to be admitted to hospital after having been properly informed,&#xD;
             and their families as well, of the possible risks that they are assuming.&#xD;
&#xD;
          -  Specific diagnosis: pulmonary edema, rib fractures, aspiration, pleural effusion, etc.&#xD;
             upon admission.&#xD;
&#xD;
          -  Other associated respiratory pathology that determines treatment: pulmonary fibrosis,&#xD;
             kyphoscoliosis, neuromuscular pathology, upper airway obstruction, extensive&#xD;
             tuberculosis sequelae.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nermeen Abdel Aleem</last_name>
    <phone>01007174772</phone>
    <email>nermeenabdelaleem@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Metwally</last_name>
    <phone>01223971614</phone>
    <email>melhadi@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chest Department-faculty of medicine-Assuit university</name>
      <address>
        <city>Assuit</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>October 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Nermeen Aly Mahmoud Abdel Aleem</investigator_full_name>
    <investigator_title>chest department- faculity of medicine -Assiut university- Egypt</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02259439
org study id: 16022012
nct id: NCT02259439
lead sponsor: 
has dmc: No
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading
      cause of morbidity and mortality.Patients admitted to hospital present higher mortality
      rates.The investigators lack the specific tools that allow us to easily classify and
      establish the individual prognosis for each patient during their hospitalization.

      Rational of the study:to identify the predictive factors for hospital mortality in critically
      ill patients admitted to hospital due to an episode of COPD exacerbation.
Material and Methods:

      A) sociodemographic variables:

      Age, sex, marital status, occupation, pack\year.

      B) clinical variables:

      1- Dyspnea measured by the Medical Research Council (MRC) scale and the COPD Assessment Test
      (CAT ) while stable, previous to admittance.

      3- Charlson comorbidity index and age adjusted model.

      4- The APACHE II scale: the severity of the episode upon admittance, calculated using the
      APACHE II scale, using the worst value obtained in the first 24h after being admitted to
      hospital.

      5- the Sequential Organ Failure Assessment (SOFA) scale.

      6- Lab parameters: such as glucose, albumin and heamatocrit

      7- BAP-65 score: elevated blood urea nitrogen, altered mental status, pulse > 109 beats/min,
      age > 65 years.

      8- Assessment of symptom of gastroesophageal reflux disease.

      9-Glasgow scale score.

      10-CURB 65 :"C" stands for "confused"; "U" stands for BUN greater than19 mg/dL; "R" stands
      for "respiration more than 30 breaths per minute""B" stands for blood pressure less than 90
      mm Hg systolic or diastolic blood pressure 60 mm Hg or less; "65" stands ≥65 years.

      11-CAUDA 70: C: Confusion, Acidosis (pH <7.35), Urea >7mmol/L, MRC Dyspnoea score >4, Albumin
      <35g/L, Age >70 years. One point was assigned to each variable present, giving a six point
      scoring system.

      12-The COPD and Asthma Physiology Score.

      13-The early warning score.

      14-ADO index: comprised of age, dyspnea by the MRC, and FEV1. Scores ranged from 0 (best
      status) to 5 (worst status) for age, 0-3 for MRC, and 0-2 for FEV1. Points for each component
      were added so that the ADO index ranged from 0 to 10.
observational model: Case-Only
time perspective: Prospective
measure: Calculate the mortality of exacerbated patients based on APACHE II and SOFA score, respiratory rate upon admittance, age, pO2/ FiO2 in the first few hours of admittance.
time frame: 24 hours
description: Calculate mortality caused by AECOPD depend upon APACHE II and SOFA score
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Nermeen Abdel Aleem
phone: 01007174772
email: nermeenabdelaleem@gmail.com
last name: Mohamed Metwally
phone: 01223971614
email: melhadi@yahoo.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Nermeen Aly Mahmoud Abdel Aleem
investigator title: chest department- faculity of medicine -Assiut university- Egypt
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive