<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/NCT04455113</url>
  </required_header>
  <id_info>
    <org_study_id>ASUH612/18</org_study_id>
    <nct_id>NCT04455113</nct_id>
  </id_info>
  <brief_title>Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU</brief_title>
  <official_title>Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ayman Anis Metry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of&#xD;
      developing morbidities other than that underlying sepsis and more vulnerable to higher&#xD;
      mortality rate. Thus, the current study hypothesized that diagnosis and management of&#xD;
      hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic&#xD;
      patients admitted to ICU&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study was started since June 2018 till Jan 2020 after approval of the study&#xD;
      protocol by the Local Ethical Committee. The study intended to include all patients admitted&#xD;
      to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.&#xD;
&#xD;
      All patients admitted to ICU were eligible to evaluation for demographic and clinical data&#xD;
      including hemodynamic data. Disease severity and its impact on body organs were evaluated&#xD;
      using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18)&#xD;
      scores. Exclusion criteria included maintenance on immunodepressent therapy for any&#xD;
      indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the&#xD;
      written concept for study participation. Children and adulthoods younger than 18 years and&#xD;
      patients who were expected to die were also excluded from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>The 28-day ICU mortality rate (28-MR)</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of additional morbidities.</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between 28-MR and incidence of additional morbidities and severity of HP.</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">317</enrollment>
  <condition>Effect of Hypophosphatemia on Septic Patients</condition>
  <arm_group>
    <arm_group_label>Normo-phosphatemia</arm_group_label>
    <description>238 patients included in this group. Phosphorus level &gt;2.5 mg/dl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypophosphatemia</arm_group_label>
    <description>79 patients included in this group. Phosphorus level &lt;2.5 mg/dl</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Phosphorus level</intervention_name>
    <description>infusion</description>
    <arm_group_label>Hypophosphatemia</arm_group_label>
    <arm_group_label>Normo-phosphatemia</arm_group_label>
    <other_name>sodium-phosphate 10 ml vial</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included all patients admitted to ICU for sepsis, severe sepsis and septic shock.&#xD;
&#xD;
        All patients included except mentioned above exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to ICU were eligible to evaluation for demographic and clinical&#xD;
             data including hemodynamic data.&#xD;
&#xD;
          -  Disease severity and its impact on body organs were evaluated using acute physiology&#xD;
             and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maintenance on immunodepressent therapy.&#xD;
&#xD;
          -  Severe hemorrhagic shock.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Refusal of nearest relative to sign the written concept for study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University hospitals</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypophosphatemia</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/NCT04455113
org study id: ASUH612/18
nct id: NCT04455113
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of
      developing morbidities other than that underlying sepsis and more vulnerable to higher
      mortality rate. Thus, the current study hypothesized that diagnosis and management of
      hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic
      patients admitted to ICU
The current study was started since June 2018 till Jan 2020 after approval of the study
      protocol by the Local Ethical Committee. The study intended to include all patients admitted
      to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.

      All patients admitted to ICU were eligible to evaluation for demographic and clinical data
      including hemodynamic data. Disease severity and its impact on body organs were evaluated
      using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18)
      scores. Exclusion criteria included maintenance on immunodepressent therapy for any
      indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the
      written concept for study participation. Children and adulthoods younger than 18 years and
      patients who were expected to die were also excluded from the study.
observational model: Case-Only
time perspective: Prospective
measure: The 28-day ICU mortality rate (28-MR)
time frame: 28 days
measure: The incidence of additional morbidities.
time frame: 30 days
measure: The correlation between 28-MR and incidence of additional morbidities and severity of HP.
time frame: 28 days
arm group label: Normo-phosphatemia
description: 238 patients included in this group. Phosphorus level >2.5 mg/dl
arm group label: Hypophosphatemia
description: 79 patients included in this group. Phosphorus level <2.5 mg/dl
intervention type: Diagnostic Test
intervention name: Phosphorus level
description: infusion
arm group label: Hypophosphatemia
arm group label: Normo-phosphatemia
other name: sodium-phosphate 10 ml vial
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
mesh term: Hypophosphatemia
sharing ipd: No