xml: <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/NCT05964088</url>
    </required_header>
    <id_info>
      <org_study_id>22-18</org_study_id>
      <nct_id>NCT05964088</nct_id>
    </id_info>
    <brief_title>Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients</brief_title>
    <official_title>Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arrowhead Regional Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arrowhead Regional Medical Center</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>
        This study explored the incidence of morbidity and mortality associated with AKI in&#xD;
        critically ill adult patients infected with COVID-19. There are two groups for comparison.&#xD;
        Group1. patients were directly admitted to the intensive care unit (ICU) from the emergency&#xD;
        department (ED) Group 2. patients were initially managed on the medical floor and later&#xD;
        transferred to the ICU for worsening respiratory status. The investigating team evaluated the&#xD;
        correlation of inflammatory markers and common risk factors such as obesity, diabetes,&#xD;
        hypertension and ethnicity to the development of AKI in the target population. The primary&#xD;
        outcome is mortality participants will received their regular healthcare in a medical setting&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2020</start_date>
    <completion_date type="Actual">February 12, 2022</completion_date>
    <primary_completion_date type="Actual">February 12, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>from admission until death from any cause, whichever comes first, assessed up to three months</time_frame>
      <description>mortality at hospital discharge</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">267</enrollment>
    <condition>Acute Kidney Injury</condition>
    <arm_group>
      <arm_group_label>Group1</arm_group_label>
      <description>These critically ill patients were directly admitted to the intensive care unit from the emergency department</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>These critically ill patients were were initially managed on the medical floor and later transferred to the intensive care unit for worsening respiratory status</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This is a two-year retrospective study of critically ill adult patients infected with&#xD;
          COVID-19 that were admitted to the intensive care unit on ventilatory support. Patients&#xD;
          included in this study were admitted to Arrowhead Regional Medical Center (ARMC) from March&#xD;
          1, 2020 to February 12, 2022.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          positive for SARS-CoV-2 on a real-time polymerase chain reaction test (RT-PCR) upon&#xD;
          admission to the hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          chronic kidney disease end stage renal disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael M Neeki, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Arrowhead Regional Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Arrowhead Regional Medical Center</name>
        <address>
          <city>Colton</city>
          <state>California</state>
          <zip>92324</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Arrowhead Regional Medical Center</investigator_affiliation>
      <investigator_full_name>Michael Neeki</investigator_full_name>
      <investigator_title>Attending Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964088
  org study id: 22-18
  nct id: NCT05964088
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study explored the incidence of morbidity and mortality associated with AKI in
        critically ill adult patients infected with COVID-19. There are two groups for comparison.
        Group1. patients were directly admitted to the intensive care unit (ICU) from the emergency
        department (ED) Group 2. patients were initially managed on the medical floor and later
        transferred to the ICU for worsening respiratory status. The investigating team evaluated the
        correlation of inflammatory markers and common risk factors such as obesity, diabetes,
        hypertension and ethnicity to the development of AKI in the target population. The primary
        outcome is mortality participants will received their regular healthcare in a medical setting
  observational model: Cohort
  time perspective: Retrospective
  measure: Mortality
  time frame: from admission until death from any cause, whichever comes first, assessed up to three months
  description: mortality at hospital discharge
  arm group label: Group1
  description: These critically ill patients were directly admitted to the intensive care unit from the emergency department
  arm group label: Group 2
  description: These critically ill patients were were initially managed on the medical floor and later transferred to the intensive care unit for worsening respiratory status
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Michael M Neeki, DO
  role: Principal Investigator
  affiliation: Arrowhead Regional Medical Center
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Arrowhead Regional Medical Center
  investigator full name: Michael Neeki
  investigator title: Attending Physician
  mesh term: Acute Kidney Injury
  mesh term: Wounds and Injuries