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    Summary
    EudraCT Number:2017-000632-34
    Sponsor's Protocol Code Number:AAUH-ICU-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2017-000632-34
    A.3Full title of the trial
    Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

    Addendum: Trial extension including only patients with SARS-CoV-2 positive tests (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxygen supplementation in patients with acute pulmonary failure admitted to the intensive care unit: A clinical trial of two seperate levels of oxygen supplementation during treatment in the intensive care unit

    Addendum: Trial extension including only COVID-19 patients
    Ilttilskud til kritisk syge voksne patienter som indlægges på en intensiv afdeling med akut lungesvigt: Et multicenter og internationalt randomiseret klinisk forsøg, hvor to niveauer af iltindhold i blodet under behandlingen undersøges

    Tillæg: Forlængelse af studie udelukkende med COVID-19 patienter
    A.3.2Name or abbreviated title of the trial where available
    Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)
    A.4.1Sponsor's protocol code numberAAUH-ICU-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03174002
    A.5.4Other Identifiers
    Name:US NCT numberNumber:NCT04425031
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnovation Fund Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Society of Anaesthesia and Intensive Care Medicine (DASAIM)
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportObel Family Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegionernes Medicinpulje
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportIntensiv Symposium Hindsgavl
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportMinistry of Higher Education and Science
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Anaesthesia and intensive Care Medicine, Aalborg University Hospital
    B.5.2Functional name of contact pointBodil Steen Rasmussen
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18-22
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4597661864
    B.5.6E-mailbodil.steen.rasmussen@rn.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Medicinal gas, cryogenic
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute hypoxaemic respiratory failure in patients admitted to the intensive care unit
    Addendum: Acute hypoxaemic respiratory failure in patients admitted to the intensive care unit with COVID-19
    E.1.1.1Medical condition in easily understood language
    Patients with acute pulmonary failure and inadequate oxygenation of the blood, admitted to an intensive care unit
    Addendum: Concerning COVID-19 patients only
    Patienter indlagt akut på en intensiv afdeling med lungesvigt
    Tillæg: Patienter indlagt akut på en intensiv afdeling med lungesvigt og COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001053
    E.1.2Term Acute respiratory failure
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10022519
    E.1.2Term Intensive care
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.
    Addendum: To assess the benefits and harms of two targets in COVID-19 patients.
    At belyse fordele og ulemper ved at tilstræbe to forskellige niveauer af iltindhold i blodet, målt ved standard målemetoden på intensiv afdeling, som er ilttrykket i pulsårerne, hos kritisk syge voksne patienter, som indlægges akut på en intensiv afdeling med lungesvigt.
    Tillæg: At belyse fordele og ulemper ved at tilstræbe to forskellige niveauer af iltindhold i blodet for COVID-19 patienter.
    E.2.2Secondary objectives of the trial
    To asses health economic implications of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission. Conducted through a health economic analysis at one year follow-up of the last enrolled patient.
    Tillæg: To asses health economic implications of the two targets in COVID-19 patients.
    At vurdere de sundhedsøkonomiske omkostninger/besparelser ved at tilstræbe to forskellige niveauer af iltindhold i blodet hos kritisk syge voksne patienter, som indlægges akut på en intensiv afdeling med lungesvigt. Dette planlagt når der er lavet et års opfølgning af den sidste inkluderede patient.
    Tillæg: At vurdere de sundhedsøkonomiske omkostninger/besparelser ved at tilstræbe to forskellige niveauer af iltindhold i blodet hos COVID-19 patienter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Acutely admitted to the intensive care unit AND
    - Aged ≥ 18 years AND
    - Receive supplemental oxygen with a flow of at least 10 L per minute in an open system or at least an fraction of inspired oxygen of 0.50 in a closed system, including invasive ventilation, non-invasive ventilation or continuous positive airway pressure AND
    - Are expected to receive oxygen administration for at least 24 hours in the ICU AND
    - Have an arterial line in place

    Addendum:
    - Acutely admitted to the intensive care unit AND
    - Aged ≥ 18 years AND
    - Supplemental oxygen with a flow of at least 10 L oxygen per minutes in an open system including high-flow systems OR invasive or non-invasive mechanical ventilation/CPAP systems independent of the FiO2 AND
    - Are expected to receive oxygen administration for at least 24 hours in the ICU AND
    - Have an arterial line in place
    - Confirmed SARS-CoV-2 infection in the time leading to or during current hospital admission
    - Akut indlagt på intensiv afdeling OG
    - Alder ≥ 18 år OG
    - Får et ilttilskud på mindst 10 liter per minut via iltkateter i næse eller gennem ansigtsmaske, eller er tilkoblet en respirator med et ilttilskud på mindst 50% OG
    - Forventes at skulle have behov for ilttilskud på den intensive afdeling i mindst 24 timer OG
    - Har et fungerende kateter anlagt i en pulsåre (arterie-kanyle)

    Tillæg:
    - Akut indlagt på intensiv afdeling OG
    - Alder ≥ 18 år OG
    - Får et ilttilskud på mindst 10 liter per minut via iltkateter i næse eller gennem ansigtsmaske, eller er tilkoblet en respirator OG
    - Forventes at skulle have behov for ilttilskud på den intensive afdeling i mindst 24 timer OG
    - Har et fungerende kateter anlagt i en pulsåre (arterie-kanyle)
    - Har påvist infektion med SARS-CoV-2 (COVID-19) i tiden op til eller under nuværende indlæggelse
    E.4Principal exclusion criteria
    - Cannot be randomised within twelve hours after present ICU admission
    - Chronic mechanical ventilation for any reason
    - Use of home oxygen
    - Previous treatment with bleomycin
    - Organ transplant during current hospital admission
    - Withdrawal from active therapy or brain death deemed imminent
    - Fertile woman with positive urine human gonadotropin (hCG) or
    plasma-hCG
    - Carbon monoxide poisoning
    - Cyanide poisoning
    - Methaemoglobinaemia
    - Paraquat poisoning
    - Any condition expected to involve the use of hyperbaric oxygen (HBO)
    - Sickle cell disease
    - Consent not obtainable according to national regulations
    - Previously randomised into the HOT-ICU trial

    Addendum: Identical criteria.
    - Inklusion til studiet kan ikke foretages indenfor de første 12 timer efter indlæggelsen på intensiv afdeling
    - Har hjemme-respirator
    - Får ilt i hjemmet
    - Er tidligere behandlet med bleomycin
    - Der er planlagt/har været foretaget en organtransplantation under indeværende indlæggelse.
    - Aktiv behandling vurderet udsigtsløs eller patienten er nært forestående hjernedød
    - Er gravid
    - Er forgiftet med kulmonooxid, cyanid eller paraquat
    - Har methæmoglobin i blodet
    - Har en tilstand, som kræver behandling med ilt under overtryk (hyperbar iltbehandling)
    - Har seglcelle sygdom
    - Det er ikke muligt at indhente informeret samtykke
    - Tidligere inkluderet i HOT-ICU forsøget

    Tillæg: Samme kriterier
    E.5 End points
    E.5.1Primary end point(s)
    Mortality

    Addendum: In COVID-19 patients days alive without the use of respiratory support, renal replacement therapy or circulatory support in the 90-day period in the trial extension.
    Dødelighed

    Addendum: Dage i live uden behandling med respirator, dialyse eller kredsløbsstimulerende medicin i 90 dage efter lodtrækningen for COVID-19 patienter i tillægsstudiet
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days post-randomisation

    Addendum: Identical.
    90 dage efter lodtrækning

    Tillæg: Identisk.
    E.5.2Secondary end point(s)
    - Number of patients with one or more SAEs in the ICU after randomisation; SAEs are defined as new episode of shock and new episodes of ischemic events including myocardial or intestinal ischaemia or ischemic stroke in the 90-day period
    - Days alive without the use of respiratory support, renal replacement therapy or circulatory support in the 90-day period
    - Days alive out of the hospital in the 90-day period
    - Mortality 1-year after randomisation
    - Health related quality of life (Euroqual, EQ-5D-5L) 1-year after randomisation.
    - Cognitive function 1-year after randomisation as assessed using RBANS score in selected sites
    - Lung function 1-year after randomisation as assessed using full body plethysmography in selected sites
    - A health economic analysis based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)

    Addendum:
    - 90-day all-cause mortality
    - Number of patients with one or more SAEs in the ICU after randomisation; SAEs are defined as new episode of shock and new episodes of ischemic events including myocardial or intestinal ischaemia or ischemic stroke in the 90-day period
    - Days alive out of the hospital in the 90-day period
    - Mortality 1-year after randomisation
    - Health related quality of life (Euroqual, EQ-5D-5L) 1-year after randomisation.
    - Cognitive function 1-year after randomisation as assessed using RBANS score in selected sites
    - Lung function 1-year after randomisation as assessed using full body plethysmography in selected sites
    - A health economic analysis based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
    - Nyopståede tilfælde af kredsløbssvigt, nyopståede tegn på vævskade i hjerte, hjerne og tarm i 90 dage efter lodtrækningen
    - Dage i live uden behandling med respirator, dialyse eller kredsløbsstimulerende medicin i 90 dage efter lodtrækningen
    - Dage i live og udskrevet fra hospitalet i 90 dage efter lodtrækningen
    - Dødelighed et år efter lodtrækningen
    - Vurdering af livskvalitet og kognitiv funktion (selekterede sites) efter et år efter lodtrækningen
    - Overordnede sundhedsøkonomiske analyser et år efter lodtrækningen af den sidste inkluderede patient.

    Tillæg:
    - 90-dages dødelighed
    - Nyopståede tilfælde af kredsløbssvigt, nyopståede tegn på vævskade i hjerte, hjerne og tarm i 90 dage efter lodtrækningen
    - Dage i live og udskrevet fra hospitalet i 90 dage efter lodtrækningen
    - Dødelighed et år efter lodtrækningen
    - Vurdering af livskvalitet og kognitiv funktion (selekterede sites) efter et år efter lodtrækningen
    - Vurdering af lungefunktion efter 1 år efter lodtrækningen
    - Overordnede sundhedsøkonomiske analyser et år efter lodtrækningen af den sidste inkluderede patient.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See description in E.5.2
    Se beskrivelse i E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Forskellig dosering af ilt. Komperatoren er det højeste oxygeneringsmål.
    Different dosage of oxygen. The comparator is the highest oxygenation target.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    Finland
    Iceland
    Netherlands
    Norway
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Trial allocation is planned to end when 2 x 1464 (2928) patients have been randomised (April 2019) and 90-days follow-up has been completed (July 2019).
    The patients will be contacted one year after randomisation (last patient contacted April 2020) to conduct follow-up on health related quality of life and cognitive function (selected sites).

    Addendum: 2 x 340 (780) patients (expected Aug. 2022) and 90-days follow-up has been completed (Nov. 2020). Last patient contact expected Nov. 2023.
    Forsøgsallokeringen er planlagt til at stoppe når 2 x 1464 (2928) patienter er blevet randomiseret (april 2019) og 90 dages opfølgning er færdiggjort (juli 2019).
    Patienterne vil blive kontaktet et år efter randomiseringen (sidste patient forventes kontaktet i april 2020) for at lave vurdering af livskvalitet og kognitiv funktion (selekterede sites).

    Tillæg: 2 x 340 (780) patienter (aug. 2022) og 90 dages opfølgning er færdiggjort (nov. 2022). Sidste patientkontakt forventes i nov. 2023.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1554
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2154
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-02-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The trial will enroll critically ill patients (emergency situations) who will be temporarily incompetent due to the severety of illness or as a consequence of the treatment (sedation and analgesics).
    Forsøget inkluderer kritisk syge patienter i akutte situationer, disse patienter vil være midlertidigt uden handleevne grundet sygdomssværhedsgraden og/eller behandlingen med bedøvelsesmidler og smertestillende medicin.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3200
    F.4.2.2In the whole clinical trial 3708
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Scandinavian Critical Care Trials Group
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Centre for Research in Intensive Care (CRIC)
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Copenhagen Trial Unit (CTU)
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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