A Phase 4 interventional study of Oxygen and Oxygen in Hypoxemic Respiratory Failure and Oxygen Toxicity, sponsored by Aalborg University Hospital. Completed at 37 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Aalborg University Hospital · Phase 4, Interventional, and Prevention
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 2,928 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)
Drug: Oxygen
Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)
Drug: Oxygen
Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
Also known as: Inspired oxygen
Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
Also known as: Inspired oxygen
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
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
Plan to share: Yes — 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 information: Study protocol, Sap, Icf
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aalborg University Hospital