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Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)

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ClinicalTrials.gov Identifier: NCT03174002
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Bodil Steen Rasmussen, Aalborg University Hospital

Tracking Information
First Submitted Date  ICMJE May 30, 2017
First Posted Date  ICMJE June 2, 2017
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE June 19, 2017
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
90-days mortality [ Time Frame: 90 days ]
Landmark mortality 90-days after randomisation
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
Mortality [ Time Frame: 90 days ]
Landmark mortality 90-days after randomisation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Days alive without organ support [ Time Frame: Within 90 days ]
    Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
  • Days alive out of the hospital [ Time Frame: Within 90 days ]
    Percentage of days alive out of the hospital
  • Number of patients with one or more serious adverse events [ Time Frame: 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
  • 1-year mortality [ Time Frame: 1 year ]
    Landmark mortality 1 year after randomisation
  • Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites [ Time Frame: 1 year ]
    EQ-5D-5L 1-year after randomisation
  • 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 ]
    RBANS score 1 year after randomisation at selected sites
  • Pulmonary function [ Time Frame: 1 year ]
    Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites
  • A health economic analysis [ Time Frame: 90 days ]
    The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • Days alive without organ support [ Time Frame: Within 90 days ]
    Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
  • Days alive out of the hospital [ Time Frame: Within 90 days ]
    Percentage of days alive out of the hospital
  • Number of patients with one or more serious adverse events [ Time Frame: 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
  • Mortality [ Time Frame: 1 year ]
    Landmark mortality 1 year after randomisation
  • Quality of life [ Time Frame: 1 year ]
    EQ-5D-5L 1-year after randomisation
  • 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 ]
    RBANS score 1 year after randomisation at selected sites
  • A health economic analysis [ Time Frame: 90 days ]
    The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Handling Oxygenation Targets in the Intensive Care Unit
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hypoxemic Respiratory Failure
  • Oxygen Toxicity
Intervention  ICMJE
  • Drug: Oxygen
    Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
    Other Name: Inspired oxygen
  • Drug: Oxygen
    Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
    Other Name: Inspired oxygen
Study Arms  ICMJE
  • Experimental: Low oxygenation target
    Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)
    Intervention: Drug: Oxygen
  • Active Comparator: High oxygenation target
    Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)
    Intervention: Drug: Oxygen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 1, 2017)
2928
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 3, 2020
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   Iceland,   Netherlands,   Norway,   Switzerland,   United Kingdom
Removed Location Countries Sweden
 
Administrative Information
NCT Number  ICMJE NCT03174002
Other Study ID Numbers  ICMJE AAUH-ICU-01
2017-000632-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All original records (incl. consent 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 (https://zenodo.org/about) and maintained for 15 years and anonymised if requested by the authorities.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Study Protocol and Statistical Analysis Plan has been published. Informed Consent Form are available on the webpage (www.cric.nu/hot-icu)
Access Criteria: Managed by the Steering Committee of the HOT-ICUT trial.
URL: https://www.cric.nu/hot-icu/
Responsible Party Bodil Steen Rasmussen, Aalborg University Hospital
Study Sponsor  ICMJE Aalborg University Hospital
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators  ICMJE
Principal Investigator: Bodil Steen Rasmussen, MD, PhD Aalborg University Hospital, Denmark
Study Chair: Anders Perner, MD, PhD Rigshospitalet, Denmark
PRS Account Aalborg University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP