Handling Oxygenation Targets in the Intensive Care Unit

Hypoxemic Respiratory Failure Clinical Trial

— HOT-ICU  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174002
• Other study ID #: AAUH-ICU-01
• Secondary ID: 2017-000632-34
• Status: Completed
• Phase: Phase 4
• Start date: June 19, 2017
• Est. completion date: August 3, 2021

Study information

• Verified date: October 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2928
• Est. completion date: August 3, 2021
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Oxygen Toxicity
• Respiratory Insufficiency

Intervention

Drug:
• Oxygen
Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
• Oxygen
Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge

Locations

Country	Name	City	State
Denmark	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	Dept. of Intensive Care, Holbæk Hospital	Holbæk
Denmark	Department of Intensive Care, Holstebro	Holstebro
Denmark	Dept. of Intensive Care, Holstebro Hospital	Holstebro
Denmark	Dept. of Intensive Care, Horsens Hospital	Horsens
Denmark	Dept. of Intensive Care, Hvidovre Hospital	Hvidovre
Denmark	Dept. of Intensive Care, Køge Hospital	Køge
Denmark	Dept. of Intensive Care, Kolding Hospital	Kolding
Denmark	Dept. of Intensive Care, Randers Hospital	Randers
Denmark	Dept. of Intensive Care, Roskilde Hospital	Roskilde
Denmark	Dept. of Intensive Care, Slagelse Hospital	Slagelse
Denmark	Department of Intensive Care, Viborg Hospital	Viborg
Finland	Dept. of Intensive Care, Helsinki University Hospital	Helsinki
Finland	Dept. of Intensive Care, Central Finland Central Hospital	Jyväskylä
Finland	Dept. of Intensive Care, Kuopio University Hospital, Kuopio	Kuopio
Finland	Dept. of Intensive Care, Turku University Hospital, Turku	Turku
Iceland	Dept. of Intensive Care, Landspitali University Hospital Reykjavik	Reykjavík
Netherlands	Dept. of Intensive Care, University Medical Center Groningen	Groningen
Netherlands	Dept. of Intensive Care, Canisius Wilhelmina Hospital	Nijmegen
Norway	Dept. of Intensive Care, National Hospital, University of Oslo	Oslo
Switzerland	Dept. of Intensive Care, Basel University Hospital	Basel
Switzerland	Dept. of Intensive Care, Bern University Hospital	Bern
United Kingdom	Department of Intensive Care, University Hospital of Wales	Cardiff	Wales
United Kingdom	Kingston Hospital NHS Foundation Trust	Kingston Upon Thames
United Kingdom	Royal Glamorgan Hospital	Llantrisant
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading	Berkshire

Sponsors (3)

Lead Sponsor	Collaborator
Aalborg University Hospital	Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Denmark

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Netherlands,  Norway,  Switzerland,  United Kingdom, 

References & Publications (5)

Barbateskovic M, Schjørring OL, Jakobsen JC, Meyhoff CS, Rasmussen BS, Perner A, Wetterslev J. Oxygen supplementation for critically ill patients-A protocol for a systematic review. Acta Anaesthesiol Scand. 2018 Aug;62(7):1020-1030. doi: 10.1111/aas.13127. Epub 2018 Apr 30. — View Citation

Barbateskovic M, Schjørring OL, Russo Krauss S, Jakobsen JC, Meyhoff CS, Dahl RM, Rasmussen BS, Perner A, Wetterslev J. Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit. Cochrane Database Syst Rev. 2019 Nov 27;2019(11). doi: 10.1002/14651858.CD012631.pub2. — View Citation

Rasmussen BS, Perner A, Wetterslev J, Meyhoff CS, Schjørring OL. Oxygenation targets in acutely ill patients: still a matter of debate. Lancet. 2018 Dec 8;392(10163):2436-2437. doi: 10.1016/S0140-6736(18)32201-3. — View Citation

Schjørring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Morgan M, Bäcklund M, Siegemund M, Thormar KM, Rasmussen BS. The handling oxygenation targets in the intensive care unit (HOT-ICU) trial: Detailed statistical analysis plan. Acta Anaesthesiol Scand. 2020 Jul;64(6):847-856. doi: 10.1111/aas.13569. Epub 2020 Mar 4. — View Citation

Schjørring OL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Okkonen M, Siegemund M, Morgan M, Thormar KM, Rasmussen BS; HOT-ICU Investigators. Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)-Protocol for a randomised clinical trial comparing a lower vs a higher oxygenation target in adults with acute hypoxaemic respiratory failure. Acta Anaesthesiol Scand. 2019 Aug;63(7):956-965. doi: 10.1111/aas.13356. Epub 2019 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-days mortality	Landmark mortality 90-days after randomisation	90 days
Secondary	Days alive without organ support	Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy	Within 90 days
Secondary	Days alive out of the hospital	Percentage of days alive out of the hospital	Within 90 days
Secondary	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	Until ICU discharge, maximum 90 days
Secondary	1-year mortality	Landmark mortality 1 year after randomisation	1 year
Secondary	Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites	EQ-5D-5L 1-year after randomisation	1 year
Secondary	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	1 year
Secondary	Pulmonary function	Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites	1 year
Secondary	A health economic analysis	The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)	90 days

External Links

•   Link to the HOT-ICU website