<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/NCT04406688</url>
  </required_header>
  <id_info>
    <org_study_id>04-AnIt-20</org_study_id>
    <nct_id>NCT04406688</nct_id>
  </id_info>
  <brief_title>Prediction of Acute Kidney Injury in Patients With COVID-19</brief_title>
  <official_title>Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Muenster</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 two biomarkers determined in urine, &quot;Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)&quot;&#xD;
      and &quot;Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)&quot;, can indicate the occurrence of&#xD;
      Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage.&#xD;
      However, no data are available whether these parameters can also predict the occurrence of&#xD;
      AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the&#xD;
      optimisation of therapeutic management to improve patient outcome and for the triage of&#xD;
      patients.&#xD;
&#xD;
      The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7]&#xD;
      can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2&#xD;
      associated acute respiratory distress syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is rapidly spreading around the&#xD;
      world. The current outbreak of infections with SARS-CoV-2 is termed Coronavirus Disease 2019&#xD;
      (COVID-19). Two other coronavirus infections, SARS in 2002-2003 and Middle East Respiratory&#xD;
      Syndrome (MERS) in 2012, both caused severe respiratory syndrome in humans. All 3 of these&#xD;
      emerging infectious diseases are caused by β-coronaviruses.&#xD;
&#xD;
      Although COVID-19 primarily affects the lungs and may cause severe hypoxemia, other organs&#xD;
      including the GI tract, heart and kidney are affected. Acute kidney injury secondary to&#xD;
      COVID-19 (COV-AKI) is reported to occur in about 15-25% of patients hospitalized with&#xD;
      COVID-19 infection. The majority of AKI cases are mild to moderate with renal replacement&#xD;
      requirement in about 25%. However, AKI was much more common in non-survivors (&gt;50%). Although&#xD;
      kidney failure appears to occur late in the course, patients may begin to develop AKI within&#xD;
      the first 3 days of hospitalization. Similar to AKI in other settings,3 COV-AKI is likely to&#xD;
      be of variable etiology. Thus, there may be a long window for treatment.&#xD;
&#xD;
      The two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and&#xD;
      insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to early predict the&#xD;
      occurrence of AKI in cardiac surgical and critically ill patients. However, there is no data&#xD;
      available whether (TIMP-2)*(IGFBP7) can predict the occurrence of AKI in the COVID19 setting.&#xD;
      Early prediction of AKI may be valuable to optimize therapeutic management in order to&#xD;
      improve patient's outcome and might be helpful to triage patients.&#xD;
&#xD;
      The goal of this observational trial is to evaluate whether (TIMP-2)*(IGFBP7) early predicts&#xD;
      the occurrence of AKI in critically ill patients with SARS-CoV2 associated ARDS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of acute kidney injury (AKI)</measure>
    <time_frame>within 7 days after beginning of moderate or severe ARDS</time_frame>
    <description>Occurence of moderate or severe AKI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence of transient and persistent AKI</measure>
    <time_frame>within 7 days after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of Renal replacement therapy during hospital stay</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of renal replacement therapy</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of vasopressor administration</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>up to 4 weeks after beginning of moderate or severe ARDS</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Concentration of pro- and antiinflammatory mediators</measure>
    <time_frame>within 7 days after beginning of moderate or severe ARDS</time_frame>
    <description>Add-on-Analysis: Concentration of interleukin (IL) 6, IL8</description>
  </other_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>COVID-19</condition>
  <condition>ARDS</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA plasma, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Moderate or severe ARDS according to the Berlin definition&#xD;
&#xD;
          2. SARS-CoV2 positive test&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
          4. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre-existing AKI&#xD;
&#xD;
          2. Severe CKD with eGFR&lt;20ml/min&#xD;
&#xD;
          3. Chronic dialysis dependency&#xD;
&#xD;
          4. Kidney transplant within the last 12 months&#xD;
&#xD;
          5. Pregnancy, breastfeeding&#xD;
&#xD;
          6. Persons with any kind of dependency on the investigator or employed by the sponsor or&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Zarbock, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Münster</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papa Giovanni XXIII Hospital</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Bortolo Hospital</name>
      <address>
        <city>Vicenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário do Porto</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital SAS de Jere</name>
      <address>
        <city>Jerez De La Frontera</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Mutua Terrassa</name>
      <address>
        <city>Terrassa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital la Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St. Thomas Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <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>


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/NCT04406688
org study id: 04-AnIt-20
nct id: NCT04406688
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)"
      and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of
      Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage.
      However, no data are available whether these parameters can also predict the occurrence of
      AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the
      optimisation of therapeutic management to improve patient outcome and for the triage of
      patients.

      The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7]
      can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2
      associated acute respiratory distress syndrome.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is rapidly spreading around the
      world. The current outbreak of infections with SARS-CoV-2 is termed Coronavirus Disease 2019
      (COVID-19). Two other coronavirus infections, SARS in 2002-2003 and Middle East Respiratory
      Syndrome (MERS) in 2012, both caused severe respiratory syndrome in humans. All 3 of these
      emerging infectious diseases are caused by β-coronaviruses.

      Although COVID-19 primarily affects the lungs and may cause severe hypoxemia, other organs
      including the GI tract, heart and kidney are affected. Acute kidney injury secondary to
      COVID-19 (COV-AKI) is reported to occur in about 15-25% of patients hospitalized with
      COVID-19 infection. The majority of AKI cases are mild to moderate with renal replacement
      requirement in about 25%. However, AKI was much more common in non-survivors (>50%). Although
      kidney failure appears to occur late in the course, patients may begin to develop AKI within
      the first 3 days of hospitalization. Similar to AKI in other settings,3 COV-AKI is likely to
      be of variable etiology. Thus, there may be a long window for treatment.

      The two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and
      insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to early predict the
      occurrence of AKI in cardiac surgical and critically ill patients. However, there is no data
      available whether (TIMP-2)*(IGFBP7) can predict the occurrence of AKI in the COVID19 setting.
      Early prediction of AKI may be valuable to optimize therapeutic management in order to
      improve patient's outcome and might be helpful to triage patients.

      The goal of this observational trial is to evaluate whether (TIMP-2)*(IGFBP7) early predicts
      the occurrence of AKI in critically ill patients with SARS-CoV2 associated ARDS.
observational model: Cohort
time perspective: Prospective
measure: Occurence of acute kidney injury (AKI)
time frame: within 7 days after beginning of moderate or severe ARDS
description: Occurence of moderate or severe AKI
measure: Occurence of transient and persistent AKI
time frame: within 7 days after beginning of moderate or severe ARDS
measure: Occurence of Renal replacement therapy during hospital stay
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Duration of renal replacement therapy
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Mortality
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Duration of mechanical ventilation
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Duration of vasopressor administration
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: ICU length of stay
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Hospital length of stay
time frame: up to 4 weeks after beginning of moderate or severe ARDS
measure: Concentration of pro- and antiinflammatory mediators
time frame: within 7 days after beginning of moderate or severe ARDS
description: Add-on-Analysis: Concentration of interleukin (IL) 6, IL8
EDTA plasma, urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Zarbock, MD
role: Study Chair
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Italy
country: Portugal
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries