<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/NCT04445259</url>
  </required_header>
  <id_info>
    <org_study_id>283672</org_study_id>
    <nct_id>NCT04445259</nct_id>
  </id_info>
  <brief_title>Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury</brief_title>
  <official_title>Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to describe the epidemiology and determine the independent risk factors for&#xD;
      mortality and acute organ injury in AKI and to assess the impact of different treatment&#xD;
      strategies on survival. This will allow the development of prevention strategies and design&#xD;
      of appropriately powered intervention studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the outbreak of coronavirus disease 2019 (COVID-19) began in December 2019 in China,&#xD;
      over 1 million people have been infected and over 55,000 have died worldwide, and these&#xD;
      numbers continue to rise. Combating this pandemic requires a multidisciplinary approach from&#xD;
      the medical research community, including translational studies to understand the&#xD;
      pathogenesis of disease, randomized controlled trials of novel and re-purposed&#xD;
      pharmacotherapies, and rigorously conducted epidemiologic studies that include granular&#xD;
      patient-level data.&#xD;
&#xD;
      Current knowledge of the clinical features and outcomes of COVID-19 is mostly limited to&#xD;
      studies from China and Italy. In one of the larger such studies, which consisted of 1099&#xD;
      patients hospitalized in mainland China, only 173 (16%) were classified as having severe&#xD;
      disease, and only 15 (1.4%) died. The study was therefore inadequately powered to determine&#xD;
      independent risk factors for death. A larger study consisting of 72,314 patients was recently&#xD;
      published by the Chinese Center for Disease Control and Prevention. This nationwide registry&#xD;
      study identified several important findings, including the striking monotonic relationship&#xD;
      between older age and greater risk of death. Important limitations of the study, however,&#xD;
      were lack of granular patient-level data and relatively few patients (&lt;5% of the cohort) who&#xD;
      were critically ill. Among critically ill patients with COVID-19, acute mortality rates have&#xD;
      been reported to be as high as 49-62%, underscoring the importance of studying this patient&#xD;
      population. Data from the United Kingdom (UK) suggest that &gt;50% of critically ill patients&#xD;
      have a degree of acute kidney injury (AKI) and &gt;20% need renal replacement therapy (RRT).&#xD;
      Mortality is particularly high in those who are mechanically ventilated and need RRT (&gt;75%).&#xD;
&#xD;
      Detailed information about the risk of AKI, contributing factors and reasons for high&#xD;
      mortality in critically ill COVID-19 patients is lacking. To meet this urgent need, the&#xD;
      investigators plan to collect clinical data from &gt;250 critically ill patients with COVID-19&#xD;
      admitted to the intensive care unit (ICU) at Guy's &amp; St Thomas' Hospital. The investigators&#xD;
      will collaborate with Dr Gupta and Prof Leaf from Harvard Medical School, Boston (US) who are&#xD;
      leading a similar study across &gt;50 sites in the United States.&#xD;
&#xD;
      The aim is to describe the epidemiology and determine the independent risk factors for&#xD;
      mortality and acute organ injury in AKI and to assess the impact of different treatment&#xD;
      strategies on survival. This will allow the development of prevention strategies and design&#xD;
      of appropriately powered intervention studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Incidence of any stage of acute kidney injury</measure>
    <time_frame>14 days</time_frame>
    <description>As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>14-day, hospital, and intensive care unit (ICU) mortality</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal recovery</measure>
    <time_frame>14 days</time_frame>
    <description>Defined by return of creatinine to &lt; 1.5 times of baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who receive renal replacement therapy</measure>
    <time_frame>14 days</time_frame>
    <description>Percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants who are dialysis dependent</measure>
    <time_frame>Through study completion, an average of 90 days</time_frame>
    <description>Percentage of participants who are dialysis dependent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free-days of vasoactive medications and mechanical ventilation</measure>
    <time_frame>Day 30</time_frame>
    <description>Days without vasoactive medications and mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of intensive care unit and hospital stay</measure>
    <time_frame>Through study completion, an average of 90 days</time_frame>
    <description>Length of intensive care unit and hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with consequences following AKI</measure>
    <time_frame>Through study completion, an average of 90 days</time_frame>
    <description>Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from illness onset to need for mechanical ventilator support</measure>
    <time_frame>Through study completion, an average of 30 days</time_frame>
    <description>Time from illness onset to need for mechanical ventilator support</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>COVID</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Critically Ill Patients with COVID-19</arm_group_label>
    <description>We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patients with confirmed diagnosis of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (aged ≥18 years)&#xD;
&#xD;
          2. Confirmed diagnosis of COVID-19&#xD;
&#xD;
          3. Hospitalized in the ICU for illness related to COVID-19&#xD;
&#xD;
          4. Any of the following:&#xD;
&#xD;
               -  Current in-patient in ICU&#xD;
&#xD;
               -  Previous in-patient in ICU and died in ICU or hospital&#xD;
&#xD;
               -  Previous in-patient in ICU and discharged from ICU alive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18 years old&#xD;
&#xD;
          2. On chronic dialysis within the last year or on dialysis at ICU admission&#xD;
&#xD;
          3. Functioning kidney transplant&#xD;
&#xD;
          4. No creatinine within 48 hours of ICU admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nuttha Lumlertgul, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's &amp; St Thomas' Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marlies Ostermann, MD, PhD</last_name>
    <phone>0044 207 188 3038</phone>
    <phone_ext>83036</phone_ext>
    <email>Marlies.Ostermann@gstt.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nuttha Lumlertgul, MD, PhD</last_name>
    <phone>0044 207 188 3038</phone>
    <phone_ext>83036</phone_ext>
    <email>Nuttha.Lumlertgul@gstt.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marlies Ostermann, MD, PhD</last_name>
      <phone>020 71883038</phone>
      <email>Marlies.Ostermann@gstt.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04445259
org study id: 283672
nct id: NCT04445259
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to describe the epidemiology and determine the independent risk factors for
      mortality and acute organ injury in AKI and to assess the impact of different treatment
      strategies on survival. This will allow the development of prevention strategies and design
      of appropriately powered intervention studies.
Since the outbreak of coronavirus disease 2019 (COVID-19) began in December 2019 in China,
      over 1 million people have been infected and over 55,000 have died worldwide, and these
      numbers continue to rise. Combating this pandemic requires a multidisciplinary approach from
      the medical research community, including translational studies to understand the
      pathogenesis of disease, randomized controlled trials of novel and re-purposed
      pharmacotherapies, and rigorously conducted epidemiologic studies that include granular
      patient-level data.

      Current knowledge of the clinical features and outcomes of COVID-19 is mostly limited to
      studies from China and Italy. In one of the larger such studies, which consisted of 1099
      patients hospitalized in mainland China, only 173 (16%) were classified as having severe
      disease, and only 15 (1.4%) died. The study was therefore inadequately powered to determine
      independent risk factors for death. A larger study consisting of 72,314 patients was recently
      published by the Chinese Center for Disease Control and Prevention. This nationwide registry
      study identified several important findings, including the striking monotonic relationship
      between older age and greater risk of death. Important limitations of the study, however,
      were lack of granular patient-level data and relatively few patients (<5% of the cohort) who
      were critically ill. Among critically ill patients with COVID-19, acute mortality rates have
      been reported to be as high as 49-62%, underscoring the importance of studying this patient
      population. Data from the United Kingdom (UK) suggest that >50% of critically ill patients
      have a degree of acute kidney injury (AKI) and >20% need renal replacement therapy (RRT).
      Mortality is particularly high in those who are mechanically ventilated and need RRT (>75%).

      Detailed information about the risk of AKI, contributing factors and reasons for high
      mortality in critically ill COVID-19 patients is lacking. To meet this urgent need, the
      investigators plan to collect clinical data from >250 critically ill patients with COVID-19
      admitted to the intensive care unit (ICU) at Guy's & St Thomas' Hospital. The investigators
      will collaborate with Dr Gupta and Prof Leaf from Harvard Medical School, Boston (US) who are
      leading a similar study across >50 sites in the United States.

      The aim is to describe the epidemiology and determine the independent risk factors for
      mortality and acute organ injury in AKI and to assess the impact of different treatment
      strategies on survival. This will allow the development of prevention strategies and design
      of appropriately powered intervention studies.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of any stage of acute kidney injury
time frame: 14 days
description: As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
measure: Mortality
time frame: 14-day, hospital, and intensive care unit (ICU) mortality
description: Mortality
measure: Renal recovery
time frame: 14 days
description: Defined by return of creatinine to < 1.5 times of baseline
measure: Percentage of patients who receive renal replacement therapy
time frame: 14 days
description: Percentage
measure: Percentage of participants who are dialysis dependent
time frame: Through study completion, an average of 90 days
description: Percentage of participants who are dialysis dependent
measure: Free-days of vasoactive medications and mechanical ventilation
time frame: Day 30
description: Days without vasoactive medications and mechanical ventilation
measure: Length of intensive care unit and hospital stay
time frame: Through study completion, an average of 90 days
description: Length of intensive care unit and hospital stay
measure: Number of participants with consequences following AKI
time frame: Through study completion, an average of 90 days
description: Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia
measure: Time from illness onset to need for mechanical ventilator support
time frame: Through study completion, an average of 30 days
description: Time from illness onset to need for mechanical ventilator support
arm group label: Critically Ill Patients with COVID-19
description: We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Nuttha Lumlertgul, MD, PhD
role: Principal Investigator
affiliation: Guy's & St Thomas' Hospital
last name: Marlies Ostermann, MD, PhD
phone: 0044 207 188 3038
phone ext: 83036
email: Marlies.Ostermann@gstt.nhs.uk
last name: Nuttha Lumlertgul, MD, PhD
phone: 0044 207 188 3038
phone ext: 83036
email: Nuttha.Lumlertgul@gstt.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Critical Illness
mesh term: Wounds and Injuries
sharing ipd: Undecided