<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/NCT04425031</url>
  </required_header>
  <id_info>
    <org_study_id>AAUH-ICU-03</org_study_id>
    <secondary_id>2017-000632-34</secondary_id>
    <nct_id>NCT04425031</nct_id>
  </id_info>
  <brief_title>Handling Oxygenation Targets in COVID-19</brief_title>
  <acronym>HOT-COVID</acronym>
  <official_title>Handling Oxygenation Targets in COVID-19 Patients With Acute Hypoxaemic Respiratory Failure in the Intensive Care Unit: A Randomised Clinical Trial of a Lower Versus a Higher Oxygenation Target</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen Trial Unit, Center for Clinical Intervention Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care&#xD;
      unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity&#xD;
      evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the&#xD;
      benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in&#xD;
      guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory&#xD;
      failure at ICU admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acutely ill adult COVID-19 patients with hypoxaemic respiratory failure admitted to the&#xD;
      intensive care unit (ICU) are at risk of life-threatening hypoxia, and are provided&#xD;
      supplementary oxygen. Liberal use of supplementary oxygen may increase the number of serious&#xD;
      adverse events including death. However, the use of supplementary oxygen therapy, and the&#xD;
      optimal oxygenation target in COVID-19 patients have not yet been studied.&#xD;
&#xD;
      The World Health Organisation (WHO) recommends an oxygen therapy during resuscitation of&#xD;
      COVID-19 patients to achieve an SpO2 of 94% or more, and 90% or more when stable&#xD;
      (non-pregnant patients). The Surviving Sepsis Campaing (SSC) recommends a conservative&#xD;
      oxygenation strategy for COVID-19 patients targeting an SpO2 no higher than 96%. Both are&#xD;
      based on a systematic review and metanalysis from 2018, investigating the association with&#xD;
      mortality and higher versus lower oxygenation strategies in critically ill patients in&#xD;
      general.&#xD;
&#xD;
      COVID-19 patients admitted to the ICU and treated with positive pressure ventilation fulfil&#xD;
      the 2012 Berlin criteria for acute respiratory distress syndrome (ARDS). Current practice&#xD;
      regarding supplementary oxygen therapy in patients with ARDS follows the regimen used in an&#xD;
      randomised clinical trial (RCT) from 2000 comparing lower versus higher tidal volumes; i.e. a&#xD;
      partial pressure of arterial oxygen (PaO2) of 55-80 mmHg (7.3-10.7 kPa) or a peripheral&#xD;
      oxygen saturation (SpO2) of 88-95%.&#xD;
&#xD;
      Of note, a recent published RCT demonstrated a lowered all-cause mortality when targeting a&#xD;
      higher oxygenation target (PaO2: 12-14 kPa [90-105 mmHg]) compared to a lower oxygenation&#xD;
      target (PaO2: 7.3-9.3 [55-70 mmHg]) in ARDS patients.&#xD;
&#xD;
      The quality and quantity of the current body of evidence regarding oxygenation targets in&#xD;
      ARDS is still low.&#xD;
&#xD;
      The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of&#xD;
      partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely&#xD;
      ill adults COVID-19 patients with hypoxaemic respiratory failure at ICU admission.&#xD;
&#xD;
      The HOT-COVID trial is an amendment to the HOT-ICU trial (NCT03174002)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days alive without organ support</measure>
    <time_frame>Within 90 days</time_frame>
    <description>Days alive and free from mechanical ventilation, circulatory support and renal replacement therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>90-days mortality</measure>
    <time_frame>90 days</time_frame>
    <description>All-cause mortality 90 days after randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days alive out of the hospital</measure>
    <time_frame>Within 90 days</time_frame>
    <description>Days alive out of the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with one or more serious adverse events</measure>
    <time_frame>Until ICU discharge, maximum 90 days</time_frame>
    <description>Serious adverse events are defined as new episode of shock and new episodes of ischaemic events including myocardial or intestinal ischaemia or ischaemic stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year mortality</measure>
    <time_frame>1 year</time_frame>
    <description>All-cause mortality 1 year after randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessement using the EuroQoL EQ-5D-5L telephone interview</measure>
    <time_frame>1 year</time_frame>
    <description>EQ-5D-5L 1-year after randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites</measure>
    <time_frame>1 year</time_frame>
    <description>RBANS score 1 year after randomisation at selected sites. The overall RBANS global cognition score, as well as each cognitive domain score, range from 40 to 160 with 100 ± 15 being the age-adjusted mean ± standard deviation. Higher scores indicate better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbon monoxide diffusion capacity</measure>
    <time_frame>1 year</time_frame>
    <description>Carbon monoxide diffusion capacity (DLCO) 1 year after randomisation at selected sites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A health economic analysis</measure>
    <time_frame>90 days</time_frame>
    <description>Cost-effectiveness versus cost-minimisation analyses after completion of the trial, based on the primary outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">726</enrollment>
  <condition>Hypoxemic Respiratory Failure</condition>
  <condition>Oxygen Toxicity</condition>
  <arm_group>
    <arm_group_label>Low oxygenation target</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High oxygenation target</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge</description>
    <arm_group_label>Low oxygenation target</arm_group_label>
    <other_name>Inspired oxygen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge</description>
    <arm_group_label>High oxygenation target</arm_group_label>
    <other_name>Inspired oxygen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acutely admitted to the ICU AND&#xD;
&#xD;
          -  Aged ≥ 18 years AND&#xD;
&#xD;
          -  Receives supplemental oxygen with a flow of at least 10 L per minutes in an open&#xD;
             system including high-flow systems OR recieves supplemental oxygen in a closed system&#xD;
             including invasive or non-invasive ventilation or continuous positive airway pressure&#xD;
             (CPAP)-systems AND&#xD;
&#xD;
          -  Expected to receive supplemental oxygen for at least 24 hours in the ICU AND&#xD;
&#xD;
          -  Having an arterial line for PaO2 monitoring AND&#xD;
&#xD;
          -  Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection&#xD;
             (COVID-19) in the time leading to or during current hospital admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot be randomised within twelve hours after present ICU admission&#xD;
&#xD;
          -  Chronic mechanical ventilation for any reason&#xD;
&#xD;
          -  Use of home oxygen&#xD;
&#xD;
          -  Previous treatment with bleomycin&#xD;
&#xD;
          -  Organ transplant during current hospital admission&#xD;
&#xD;
          -  Withdrawal from active therapy or brain death deemed imminent&#xD;
&#xD;
          -  Fertile woman (&lt; 50 years of age) with positive urine human gonadotropin (hCG) or&#xD;
             plasma-hCG&#xD;
&#xD;
          -  Carbon monoxide poisoning&#xD;
&#xD;
          -  Cyanide poisoning&#xD;
&#xD;
          -  Methaemoglobinaemia&#xD;
&#xD;
          -  Paraquat poisoning&#xD;
&#xD;
          -  Any condition expected to involve the use of hyperbaric oxygen (HBO)&#xD;
&#xD;
          -  Sickle cell disease&#xD;
&#xD;
          -  Consent not obtainable according to national regulations&#xD;
&#xD;
          -  Previously randomised into the HOT-COVID trial&#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>Bodil Steen Rasmussen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bodil Steen Rasmussen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Intensive Care, Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Intensive Care, Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Intensive Care, Hillerød Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Intensive Care, Kolding Hospital</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Intensive Care, Køge Hospital</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Randers Hospital</name>
      <address>
        <city>Randers</city>
        <zip>8930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Intensive Care, Slagelse Hospital</name>
      <address>
        <city>Slagelse</city>
        <zip>4200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Norway</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://cric.nu/hot-covid</url>
    <description>Link to the HOT-COVID website</description>
  </link>
  <reference>
    <citation>Schjorring OL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Okkonen M, Siegemund M, Morgan M, Thormar KM, Rasmussen BS; HOT-ICU Investigators. Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)-Protocol for a randomised clinical trial comparing a lower vs a higher oxygenation target in adults with acute hypoxaemic respiratory failure. Acta Anaesthesiol Scand. 2019 Aug;63(7):956-965. doi: 10.1111/aas.13356. Epub 2019 Mar 18.</citation>
    <PMID>30883686</PMID>
  </reference>
  <reference>
    <citation>Barbateskovic M, Schjorring OL, Jakobsen JC, Meyhoff CS, Rasmussen BS, Perner A, Wetterslev J. Oxygen supplementation for critically ill patients-A protocol for a systematic review. Acta Anaesthesiol Scand. 2018 Aug;62(7):1020-1030. doi: 10.1111/aas.13127. Epub 2018 Apr 30.</citation>
    <PMID>29708586</PMID>
  </reference>
  <reference>
    <citation>Barbateskovic M, Schjorring OL, Russo Krauss S, Jakobsen JC, Meyhoff CS, Dahl RM, Rasmussen BS, Perner A, Wetterslev J. Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit. Cochrane Database Syst Rev. 2019 Nov 27;2019(11):CD012631. doi: 10.1002/14651858.CD012631.pub2.</citation>
    <PMID>31773728</PMID>
  </reference>
  <reference>
    <citation>Rasmussen BS, Perner A, Wetterslev J, Meyhoff CS, Schjorring OL. Oxygenation targets in acutely ill patients: still a matter of debate. Lancet. 2018 Dec 8;392(10163):2436-2437. doi: 10.1016/S0140-6736(18)32201-3. No abstract available.</citation>
    <PMID>30527413</PMID>
  </reference>
  <reference>
    <citation>Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Morgan M, Backlund M, Siegemund M, Thormar KM, Rasmussen BS. The handling oxygenation targets in the intensive care unit (HOT-ICU) trial: Detailed statistical analysis plan. Acta Anaesthesiol Scand. 2020 Jul;64(6):847-856. doi: 10.1111/aas.13569. Epub 2020 Mar 4.</citation>
    <PMID>32068884</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Bodil Steen Rasmussen</investigator_full_name>
    <investigator_title>Clinical Professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Oxygenation</keyword>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>Mechanical ventilation</keyword>
  <keyword>Critical illness</keyword>
  <keyword>Critical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All original records (incl. consent forms, electronic clinical report forms (eCRFs), and relevant correspondences) will be archived at trial sites for 15 years. The clean electronic trial database file will be delivered to the EudraCT Database and Zenodo data repository (https://zenodo.org/) and maintained for 15 years and anonymised if requested by the authorities.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_access_criteria>Access Criteria:&#xD;
Managed by the Steering Committee of the HOT-COVID trial.</ipd_access_criteria>
    <ipd_url>http://cric.nu/hot-covid</ipd_url>
  </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/NCT04425031
org study id: AAUH-ICU-03
secondary id: 2017-000632-34
nct id: NCT04425031
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care
      unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity
      evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the
      benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in
      guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory
      failure at ICU admission.
Acutely ill adult COVID-19 patients with hypoxaemic respiratory failure admitted to the
      intensive care unit (ICU) are at risk of life-threatening hypoxia, and are provided
      supplementary oxygen. Liberal use of supplementary oxygen may increase the number of serious
      adverse events including death. However, the use of supplementary oxygen therapy, and the
      optimal oxygenation target in COVID-19 patients have not yet been studied.

      The World Health Organisation (WHO) recommends an oxygen therapy during resuscitation of
      COVID-19 patients to achieve an SpO2 of 94% or more, and 90% or more when stable
      (non-pregnant patients). The Surviving Sepsis Campaing (SSC) recommends a conservative
      oxygenation strategy for COVID-19 patients targeting an SpO2 no higher than 96%. Both are
      based on a systematic review and metanalysis from 2018, investigating the association with
      mortality and higher versus lower oxygenation strategies in critically ill patients in
      general.

      COVID-19 patients admitted to the ICU and treated with positive pressure ventilation fulfil
      the 2012 Berlin criteria for acute respiratory distress syndrome (ARDS). Current practice
      regarding supplementary oxygen therapy in patients with ARDS follows the regimen used in an
      randomised clinical trial (RCT) from 2000 comparing lower versus higher tidal volumes; i.e. a
      partial pressure of arterial oxygen (PaO2) of 55-80 mmHg (7.3-10.7 kPa) or a peripheral
      oxygen saturation (SpO2) of 88-95%.

      Of note, a recent published RCT demonstrated a lowered all-cause mortality when targeting a
      higher oxygenation target (PaO2: 12-14 kPa [90-105 mmHg]) compared to a lower oxygenation
      target (PaO2: 7.3-9.3 [55-70 mmHg]) in ARDS patients.

      The quality and quantity of the current body of evidence regarding oxygenation targets in
      ARDS is still low.

      The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of
      partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely
      ill adults COVID-19 patients with hypoxaemic respiratory failure at ICU admission.

      The HOT-COVID trial is an amendment to the HOT-ICU trial (NCT03174002)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Days alive without organ support
time frame: Within 90 days
description: Days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
measure: 90-days mortality
time frame: 90 days
description: All-cause mortality 90 days after randomisation
measure: Days alive out of the hospital
time frame: Within 90 days
description: Days alive out of the hospital
measure: Number of patients with one or more serious adverse events
time frame: Until ICU discharge, maximum 90 days
description: Serious adverse events are defined as new episode of shock and new episodes of ischaemic events including myocardial or intestinal ischaemia or ischaemic stroke
measure: 1-year mortality
time frame: 1 year
description: All-cause mortality 1 year after randomisation
measure: Quality of life assessement using the EuroQoL EQ-5D-5L telephone interview
time frame: 1 year
description: EQ-5D-5L 1-year after randomisation
measure: Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites
time frame: 1 year
description: RBANS score 1 year after randomisation at selected sites. The overall RBANS global cognition score, as well as each cognitive domain score, range from 40 to 160 with 100 ± 15 being the age-adjusted mean ± standard deviation. Higher scores indicate better performance.
measure: Carbon monoxide diffusion capacity
time frame: 1 year
description: Carbon monoxide diffusion capacity (DLCO) 1 year after randomisation at selected sites.
measure: A health economic analysis
time frame: 90 days
description: Cost-effectiveness versus cost-minimisation analyses after completion of the trial, based on the primary outcome.
arm group label: Low oxygenation target
arm group type: Experimental
description: Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)
arm group label: High oxygenation target
arm group type: Active Comparator
description: Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)
intervention type: Drug
intervention name: Oxygen
description: Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
arm group label: Low oxygenation target
other name: Inspired oxygen
intervention type: Drug
intervention name: Oxygen
description: Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
arm group label: High oxygenation target
other name: Inspired oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bodil Steen Rasmussen, MD, PhD
role: Principal Investigator
affiliation: Aalborg University Hospital, Denmark
last name: Bodil Steen Rasmussen, MD, PhD
role: Study Chair
affiliation: Aalborg University Hospital, Denmark
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Norway
country: Switzerland
url: http://cric.nu/hot-covid
description: Link to the HOT-COVID website
citation: Schjorring OL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Okkonen M, Siegemund M, Morgan M, Thormar KM, Rasmussen BS; HOT-ICU Investigators. Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)-Protocol for a randomised clinical trial comparing a lower vs a higher oxygenation target in adults with acute hypoxaemic respiratory failure. Acta Anaesthesiol Scand. 2019 Aug;63(7):956-965. doi: 10.1111/aas.13356. Epub 2019 Mar 18.
PMID: 30883686
citation: Barbateskovic M, Schjorring OL, Jakobsen JC, Meyhoff CS, Rasmussen BS, Perner A, Wetterslev J. Oxygen supplementation for critically ill patients-A protocol for a systematic review. Acta Anaesthesiol Scand. 2018 Aug;62(7):1020-1030. doi: 10.1111/aas.13127. Epub 2018 Apr 30.
PMID: 29708586
citation: Barbateskovic M, Schjorring OL, Russo Krauss S, Jakobsen JC, Meyhoff CS, Dahl RM, Rasmussen BS, Perner A, Wetterslev J. Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit. Cochrane Database Syst Rev. 2019 Nov 27;2019(11):CD012631. doi: 10.1002/14651858.CD012631.pub2.
PMID: 31773728
citation: Rasmussen BS, Perner A, Wetterslev J, Meyhoff CS, Schjorring OL. Oxygenation targets in acutely ill patients: still a matter of debate. Lancet. 2018 Dec 8;392(10163):2436-2437. doi: 10.1016/S0140-6736(18)32201-3. No abstract available.
PMID: 30527413
citation: Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Morgan M, Backlund M, Siegemund M, Thormar KM, Rasmussen BS. The handling oxygenation targets in the intensive care unit (HOT-ICU) trial: Detailed statistical analysis plan. Acta Anaesthesiol Scand. 2020 Jul;64(6):847-856. doi: 10.1111/aas.13569. Epub 2020 Mar 4.
PMID: 32068884
responsible party type: Principal Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Bodil Steen Rasmussen
investigator title: Clinical Professor, MD, PhD
mesh term: Respiratory Insufficiency
sharing ipd: Yes
ipd description: All original records (incl. consent forms, electronic clinical report forms (eCRFs), and relevant correspondences) will be archived at trial sites for 15 years. The clean electronic trial database file will be delivered to the EudraCT Database and Zenodo data repository (https://zenodo.org/) and maintained for 15 years and anonymised if requested by the authorities.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd access criteria: Access Criteria:
Managed by the Steering Committee of the HOT-COVID trial.
ipd url: http://cric.nu/hot-covid