Acute hypoxaemic respiratory failure in patients admitted to the intensive care unit Addendum: Acute hypoxaemic respiratory failure in patients admitted to the intensive care unit with COVID-19 MedDRA version: 21.1 Level: PT Classification code 10001053 Term: Acute respiratory failure System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical
Conditions
Interventions
Pharmaceutical Form: Medicinal gas, cryogenic
Sponsors
Department of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Acutely admitted to the intensive care unit AND - Aged = 18 years AND - Receive supplemental oxygen with a flow of at least 10 L per minute in an open system or at least an fraction of inspired oxygen of 0.50 in a closed system, including invasive ventilation, non-invasive ventilation or continuous positive airway pressure AND - Are expected to receive oxygen administration for at least 24 hours in the ICU AND - Have an arterial line in place Addendum: - Acutely admitted to the intensive care unit AND - Aged = 18 years AND - Supplemental oxygen with a flow of at least 10 L oxygen per minutes in an open system including high-flow systems OR invasive or non-invasive mechanical ventilation/CPAP systems independent of the FiO2 AND - Are expected to receive oxygen administration for at least 24 hours in the ICU AND - Have an arterial line in place - Confirmed SARS-CoV-2 infection in the time leading to or during current hospital admission Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1554 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2154
Exclusion criteria
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 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 Addendum: Identical criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission. Addendum: To assess the benefits and harms of two targets in COVID-19 patients.;Secondary Objective: To asses health economic implications of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission. Conducted through a health economic analysis at one year follow-up of the last enrolled patient. Tillæg: To asses health economic implications of the two targets in COVID-19 patients.;Primary end point(s): Mortality Addendum: In COVID-19 patients days alive without the use of respiratory support, renal replacement therapy or circulatory support in the 90-day period in the trial extension.;Timepoint(s) of evaluation of this end point: 90 days post-randomisation Addendum: Identical. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients with one or more SAEs in the ICU after randomisation; SAEs are defined as new episode of shock and new episodes of ischemic events including myocardial or intestinal ischaemia or ischemic stroke in the 90-day period - Days alive without the use of respiratory support, renal replacement therapy or circulatory support in the 90-day period - Days alive out of the hospital in the 90-day period - Mortality 1-year after randomisation - Health related quality of life (Euroqual, EQ-5D-5L) 1-year after randomisation. - Cognitive function 1-year after randomisation as assessed using RBANS score in selected sites - Lung function 1-year after randomisation as assessed using full body plethysmography in selected sites - A health economic analysis based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses) Addendum: - 90-day all-cause mortality - Number of patients with one or more SAEs in the ICU after randomisation; SAEs are defined as new episode of shock and new episodes of ischemic events including myocardial or intestinal ischaemia or ischemic stroke in the 90-day period - Days alive out of the hospital in the 90-day period - Mortality 1-year after randomisation - Health related quality of life (Euroqual, EQ-5D-5L) 1-year after randomisation. - Cognitive function 1-year after randomisation as assessed using RBANS score in selected sites - Lung function 1-year after randomisation as assessed using full body plethysmography in selected sites - A health economic analysis based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses);Timepoint(s) of evaluation of this end point: See description in E.5.2 | — |
Countries
Denmark, Finland, Iceland, Netherlands, Norway, Switzerland, United Kingdom
Contacts
Public ContactBodil Steen Rasmussen
Department of Anaesthesia and intensive Care Medicine, Aalborg University Hospital
Outcome results
None listed