<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/NCT04404972</url>
  </required_header>
  <id_info>
    <org_study_id>CT0012020</org_study_id>
    <nct_id>NCT04404972</nct_id>
  </id_info>
  <brief_title>Incidence of Complications of Brain Death</brief_title>
  <official_title>Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brno University Hospital</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 purpose of the study is to describe the incidence of complications in brain death adult&#xD;
      organ donors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pathophysiological changes following brain death may complicate the care of brain death&#xD;
      donors. These complications negatively affects function of donated organs. Understanding&#xD;
      these complications and its incidence is crucial for their appropriate management. The aim of&#xD;
      this retrospective observational study is to evaluate the incidence of complications in adult&#xD;
      brain death organ donors. Date will be collected from medical records of eligible patients&#xD;
      admitted to intensive care unit for suspected brain death in whom brain death was confirmed&#xD;
      and who become organ donors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2022</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Hypotension</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Hypotension is defined as increase of vasoactive drug dose by 20% or systolic blood pressure lower than 90 mmHg or need for fluid resuscitation after initial normovolemia was achieved</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum lactate level</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Maximal lactate level will be evaluated during ICU stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Catecholamine storm</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Catecholamine storm is defined as onset of tachycardia and/or hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Myocardial dysfunction</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Myocardial dysfunction is defined as left ventricle ejection fraction under 50% on trans-thoracic echocardiography or S-T segment depression or elevation or T wave negativity or positive troponin serum level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ARDS</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>ARDS is defined and stratified according to Berlin definition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygenation index</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Oxygenation index will be calculated as PaO2 divided by FiO2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes insipidus</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Diabetes insipidus is defines as urine output more than 4ml/kg per hour or urine specific gravity under 1010</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal dysfunction</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Renal dysfunction is defined as presence of at least one of these criteria: absolute increase in serum creatinine ≥0.3 mg/dL (≥26.4 μmol/L) or increase in serum creatinine ≥1.5x above baseline or oliguria (urine output &lt;0.5 mL/kg per hour) for &gt;6 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coagulopathy</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Coagulopathy is defined as international normalised ratio above 1,5 or platelet count below 100 000 per microliter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypothermia</measure>
    <time_frame>48hours prior confirmation of brain death to ICU discharge</time_frame>
    <description>Body temperature below 36°C or need for external warming</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Brain Death</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patinets with confirmed brain death admitted to university hospital&#xD;
        who become brain death organ donor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥18 years&#xD;
&#xD;
          -  confirmed brain death&#xD;
&#xD;
          -  organ donor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - age under 18 years&#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>Roman Gal, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Brno</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ondrej Hrdy, MD</last_name>
    <phone>532233850</phone>
    <phone_ext>+420</phone_ext>
    <email>hrdy.ondrej@fnbrno.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Viktor Agalarev, MD</last_name>
    <phone>532233850</phone>
    <phone_ext>+420</phone_ext>
    <email>agalarev.viktor@fnbrno.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Brno</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Viktor Agalarev, M.D.</last_name>
      <phone>+420532233850</phone>
      <email>agalarev.viktor@fnbrno.cz</email>
    </contact>
    <contact_backup>
      <last_name>Ondrej Hrdy, M.D.</last_name>
      <phone>+420532233850</phone>
      <email>hrdy.ondrej@fnbrno.cz</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Ondrej Hrdy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Brain Death</keyword>
  <keyword>Organ Donation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Death</mesh_term>
    <mesh_term>Death</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/NCT04404972
org study id: CT0012020
nct id: NCT04404972
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to describe the incidence of complications in brain death adult
      organ donors.
Pathophysiological changes following brain death may complicate the care of brain death
      donors. These complications negatively affects function of donated organs. Understanding
      these complications and its incidence is crucial for their appropriate management. The aim of
      this retrospective observational study is to evaluate the incidence of complications in adult
      brain death organ donors. Date will be collected from medical records of eligible patients
      admitted to intensive care unit for suspected brain death in whom brain death was confirmed
      and who become organ donors.
observational model: Cohort
time perspective: Retrospective
measure: Hypotension
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Hypotension is defined as increase of vasoactive drug dose by 20% or systolic blood pressure lower than 90 mmHg or need for fluid resuscitation after initial normovolemia was achieved
measure: Serum lactate level
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Maximal lactate level will be evaluated during ICU stay
measure: Catecholamine storm
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Catecholamine storm is defined as onset of tachycardia and/or hypertension
measure: Myocardial dysfunction
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Myocardial dysfunction is defined as left ventricle ejection fraction under 50% on trans-thoracic echocardiography or S-T segment depression or elevation or T wave negativity or positive troponin serum level
measure: ARDS
time frame: 48hours prior confirmation of brain death to ICU discharge
description: ARDS is defined and stratified according to Berlin definition
measure: Oxygenation index
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Oxygenation index will be calculated as PaO2 divided by FiO2
measure: Diabetes insipidus
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Diabetes insipidus is defines as urine output more than 4ml/kg per hour or urine specific gravity under 1010
measure: Renal dysfunction
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Renal dysfunction is defined as presence of at least one of these criteria: absolute increase in serum creatinine ≥0.3 mg/dL (≥26.4 μmol/L) or increase in serum creatinine ≥1.5x above baseline or oliguria (urine output <0.5 mL/kg per hour) for >6 hours
measure: Coagulopathy
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Coagulopathy is defined as international normalised ratio above 1,5 or platelet count below 100 000 per microliter
measure: Hypothermia
time frame: 48hours prior confirmation of brain death to ICU discharge
description: Body temperature below 36°C or need for external warming
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roman Gal, MD, PhD
role: Study Chair
affiliation: University Hospital Brno
last name: Ondrej Hrdy, MD
phone: 532233850
phone ext: +420
email: hrdy.ondrej@fnbrno.cz
last name: Viktor Agalarev, MD
phone: 532233850
phone ext: +420
email: agalarev.viktor@fnbrno.cz
facility: 
status: Recruiting
contact: 
contact backup: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Ondrej Hrdy
investigator title: Principal Investigator
mesh term: Brain Death
mesh term: Death
sharing ipd: No