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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,928
90-days mortality
Landmark mortality 90-days after randomisation
Time frame: 90 days
Days alive without organ support
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Time frame: Within 90 days
Days alive out of the hospital
Percentage of days alive out of the hospital
Time frame: Within 90 days
Number of patients with one or more serious adverse events
Serious adverse events are defined as new episode of shock and new episodes of ischaemic events including myocardial or intestinal ischaemia or ischaemic stroke
Time frame: Until ICU discharge, maximum 90 days
1-year mortality
Landmark mortality 1 year after randomisation
Time frame: 1 year
Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites
EQ-5D-5L 1-year after randomisation
Time frame: 1 year
Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites
RBANS score 1 year after randomisation at selected sites
Time frame: 1 year
Pulmonary function
Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites
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Dept. of Intensive Care, Aalborg University Hospital
Aalborg, Denmark
Dept. of Intensive Care East Section, Øst, Skejby, Aarhus University Hospital
Aarhus, Denmark
Dept. of Intensive Care Section Nord, Skejby, Aarhus University Hospital
Aarhus, Denmark
Dept. of Intensive Care, University Hospital Skejby
Aarhus, Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Dept. of Intensive Care, Bispebjerg Hospital
Copenhagen, Denmark
Dept. of Intensive Care, Herlev Hospital
Herlev, Denmark
Dept. of Intensive Care, Herning Hospital
Herning, Denmark
Dept. of Intensive Care, Hillerød Hospital
Hillerød, Denmark
Dept. of Intensive Care, Hjørring Hospital
Hjørring, Denmark
...and 27 more locations
Time frame: 1 year
A health economic analysis
The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
Time frame: 90 days