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NCT Number: NCT03174002

Handling Oxygenation Targets in the Intensive Care Unit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Intensive Care, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge

Other names: Inspired oxygen

Primary outcomes

  1. 90-days mortality

    Time frame: 90 days

    Landmark mortality 90-days after randomisation

Secondary outcomes

  1. 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

  2. Days alive out of the hospital

    Time frame: Within 90 days

    Percentage of days alive out of the hospital

  3. 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

  4. 1-year mortality

    Time frame: 1 year

    Landmark mortality 1 year after randomisation

  5. 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

  6. 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

  7. Pulmonary function

    Time frame: 1 year

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

  8. 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)

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

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

Registry information

Official study 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

Acronym: HOT-ICU

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 2, 2017
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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