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HOT-ICU: Handling Oxygenation Targets in the Intensive Care Unit

Sponsor
Aalborg University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03174002
Collaborator
Rigshospitalet, Denmark (Other), Copenhagen Trial Unit, Center for Clinical Intervention Research (Other)
2,928
Enrollment
37
Locations
2
Arms
49.5
Actual Duration (Months)
79.1
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU), however the quality and quantity of evidence is low and potential harm has been reported. The aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory failure in the ICU.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Acutely ill adults with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and thus oxygen is administered. However, the evidence on the optimal level of oxygenation is of low quantity and quality with no firm evidence for benefit or harm. Importantly, liberal use of supplementary oxygen may increase the number of serious adverse events including death. The aim of the HOT-ICU trial is to assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

Study Design

Study Type:
Interventional
Actual Enrollment :
2928 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Jun 19, 2017
Actual Primary Completion Date :
Nov 3, 2020
Actual Study Completion Date :
Aug 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low oxygenation target

Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)

Drug: Oxygen
Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
Other Names:
  • Inspired oxygen

    		•
    Active Comparator: High oxygenation target

    Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)

    Drug: Oxygen
    Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
    Other Names:
  • Inspired oxygen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 90-days mortality [90 days]

      Landmark mortality 90-days after randomisation

    Secondary Outcome Measures

    1. Days alive without organ support [Within 90 days]

      Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy

    2. Days alive out of the hospital [Within 90 days]

      Percentage of days alive out of the hospital

    3. Number of patients with one or more serious adverse events [Until ICU discharge, maximum 90 days]

      Serious adverse events are defined as new episode of shock and new episodes of ischaemic events including myocardial or intestinal ischaemia or ischaemic stroke

    4. 1-year mortality [1 year]

      Landmark mortality 1 year after randomisation

    5. Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites [1 year]

      EQ-5D-5L 1-year after randomisation

    6. Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites [1 year]

      RBANS score 1 year after randomisation at selected sites

    7. Pulmonary function [1 year]

      Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites

    8. A health economic analysis [90 days]

      The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Acutely admitted to the ICU AND

    • Aged ≥ 18 years AND

    • Receives supplemental oxygen with a flow of at least 10 L per minutes in an open system including high-flow systems OR at least a FiO2 of 0.50 in a closed system including invasive or non-invasive ventilation or CPAP systems AND

    • Expected to receive supplemental oxygen for at least 24 hours in the ICU AND

    • Having an arterial line for PaO2 monitoring

    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 (< 50 years of age) 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Intensive Care, Aalborg University Hospital Aalborg Denmark 9000
    2 Dept. of Intensive Care East Section, Øst, Skejby, Aarhus University Hospital Aarhus Denmark 8000
    3 Dept. of Intensive Care Section Nord, Skejby, Aarhus University Hospital Aarhus Denmark 8000
    4 Dept. of Intensive Care, University Hospital Skejby Aarhus Denmark 8200
    5 Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet Copenhagen Denmark 2100
    6 Dept. of Intensive Care, Bispebjerg Hospital Copenhagen Denmark 2400
    7 Dept. of Intensive Care, Herlev Hospital Herlev Denmark 2730
    8 Dept. of Intensive Care, Herning Hospital Herning Denmark 7400
    9 Dept. of Intensive Care, Hillerød Hospital Hillerød Denmark 3400
    10 Dept. of Intensive Care, Hjørring Hospital Hjørring Denmark 9800
    11 Dept. of Intensive Care, Holbæk Hospital Holbæk Denmark 4300
    12 Department of Intensive Care, Holstebro Holstebro Denmark 7500
    13 Dept. of Intensive Care, Holstebro Hospital Holstebro Denmark 7500
    14 Dept. of Intensive Care, Horsens Hospital Horsens Denmark 8700
    15 Dept. of Intensive Care, Hvidovre Hospital Hvidovre Denmark 2650
    16 Dept. of Intensive Care, Kolding Hospital Kolding Denmark 6000
    17 Dept. of Intensive Care, Køge Hospital Køge Denmark 4600
    18 Dept. of Intensive Care, Randers Hospital Randers Denmark 8930
    19 Dept. of Intensive Care, Roskilde Hospital Roskilde Denmark 4000
    20 Dept. of Intensive Care, Slagelse Hospital Slagelse Denmark 4200
    21 Department of Intensive Care, Viborg Hospital Viborg Denmark 8800
    22 Dept. of Intensive Care, Helsinki University Hospital Helsinki Finland
    23 Dept. of Intensive Care, Central Finland Central Hospital Jyväskylä Finland 40620
    24 Dept. of Intensive Care, Kuopio University Hospital, Kuopio Kuopio Finland 70210
    25 Dept. of Intensive Care, Turku University Hospital, Turku Turku Finland 20520
    26 Dept. of Intensive Care, Landspitali University Hospital Reykjavik Reykjavík Iceland
    27 Dept. of Intensive Care, University Medical Center Groningen Groningen Netherlands 9713
    28 Dept. of Intensive Care, Canisius Wilhelmina Hospital Nijmegen Netherlands 6532 SZ
    29 Dept. of Intensive Care, National Hospital, University of Oslo Oslo Norway
    30 Dept. of Intensive Care, Basel University Hospital Basel Switzerland 4056
    31 Dept. of Intensive Care, Bern University Hospital Bern Switzerland 3010
    32 Royal Berkshire NHS Foundation Trust Reading Berkshire United Kingdom RG1 5AN
    33 Department of Intensive Care, University Hospital of Wales Cardiff Wales United Kingdom
    34 Kingston Hospital NHS Foundation Trust Kingston Upon Thames United Kingdom KT2 7QB
    35 Royal Glamorgan Hospital Llantrisant United Kingdom CF72 8XR
    36 Manchester University NHS Foundation Trust Manchester United Kingdom M13 9WL
    37 Wythenshawe Hospital Manchester United Kingdom M23 9LT

    Sponsors and Collaborators

    • Aalborg University Hospital
    • Rigshospitalet, Denmark
    • Copenhagen Trial Unit, Center for Clinical Intervention Research

    Investigators

    • Principal Investigator: Bodil Steen Rasmussen, MD, PhD, Aalborg University Hospital, Denmark
    • Study Chair: Anders Perner, MD, PhD, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Bodil Steen Rasmussen, Clinical Professor, MD, PhD, Aalborg University Hospital
    ClinicalTrials.gov Identifier:
    NCT03174002
    Other Study ID Numbers:
    • AAUH-ICU-01
    • 2017-000632-34
    First Posted:
    Jun 2, 2017
    Last Update Posted:
    Oct 26, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Bodil Steen Rasmussen, Clinical Professor, MD, PhD, Aalborg University Hospital
    Oxygenation
    Acute Respiratory Distress Syndrome
    Mechanical ventilation
    Critical illness
    Critical care
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Oct 26, 2021