Oxygen
DrugOxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
Other names: Inspired oxygen
NCT Number: NCT03174002
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Dept. of Intensive Care, Aalborg University Hospital, Aalborg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
Other names: Inspired oxygen
Time frame: 90 days
Landmark mortality 90-days after randomisation
Time frame: Within 90 days
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Time frame: Within 90 days
Percentage of days alive out of the hospital
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
Time frame: 1 year
Landmark mortality 1 year after randomisation
Time frame: 1 year
EQ-5D-5L 1-year after randomisation
Time frame: 1 year
RBANS score 1 year after randomisation at selected sites
Time frame: 1 year
Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites
Time frame: 90 days
The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
Aalborg University Hospital
Other
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
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