Handling Oxygenation Targets in the Intensive Care Unit

Phase 4

Completed

• Conditions: Oxygen Toxicity; Hypoxemic Respiratory Failure
• Interventions: Drug: Oxygen

• Registration Number: NCT03174002
• Lead Sponsor: Aalborg University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-02
• Study Start: 2017-06-19
• Primary Completion: 2020-11-03
• Study Completion: 2021-08-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-24
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2928

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High oxygenation target	Oxygen	Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)
Low oxygenation target	Oxygen	Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)

Primary Outcome Measures

Name	Time	Method
90-days mortality	90 days	Landmark mortality 90-days after randomisation

Secondary Outcome Measures

Name	Time	Method
Pulmonary function	1 year	Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites
A health economic analysis	90 days	The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
1-year mortality	1 year	Landmark mortality 1 year after randomisation
Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites	1 year	EQ-5D-5L 1-year after randomisation
Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites	1 year	RBANS score 1 year after randomisation at selected sites
Days alive without organ support	Within 90 days	Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Number of patients with one or more serious adverse events	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
Days alive out of the hospital	Within 90 days	Percentage of days alive out of the hospital

Trial Locations

Locations (37)

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, University Hospital Skejby; 🇩🇰 Aarhus, Denmark

Dept. of Intensive Care, Bispebjerg Hospital; 🇩🇰 Copenhagen, 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

Dept. of Intensive Care, Holstebro Hospital; 🇩🇰 Holstebro, Denmark

Dept. of Intensive Care, Kolding Hospital; 🇩🇰 Kolding, Denmark

Department of Intensive Care, Holstebro; 🇩🇰 Holstebro, Denmark

Dept. of Intensive Care, Horsens Hospital; 🇩🇰 Horsens, Denmark

Dept. of Intensive Care, Køge Hospital; 🇩🇰 Køge, Denmark

Dept. of Intensive Care, Hvidovre Hospital; 🇩🇰 Hvidovre, 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, Denmark

Dept. of Intensive Care, Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Dept. of Intensive Care, Kuopio University Hospital, Kuopio; 🇫🇮 Kuopio, Finland

Kingston Hospital NHS Foundation Trust; 🇬🇧 Kingston Upon Thames, United Kingdom

Dept. of Intensive Care, National Hospital, University of Oslo; 🇳🇴 Oslo, Norway

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, Berkshire, United Kingdom

Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom

Royal Glamorgan Hospital; 🇬🇧 Llantrisant, United Kingdom

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Dept. of Intensive Care Section Nord, Skejby, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Dept. of Intensive Care, Herlev Hospital; 🇩🇰 Herlev, Denmark

Dept. of Intensive Care, Herning Hospital; 🇩🇰 Herning, Denmark

Dept. of Intensive Care, Turku University Hospital, Turku; 🇫🇮 Turku, Finland

Dept. of Intensive Care, Landspitali University Hospital Reykjavik; 🇮🇸 Reykjavík, Iceland

Dept. of Intensive Care, University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Dept. of Intensive Care, Basel University Hospital; 🇨🇭 Basel, Switzerland

Dept. of Intensive Care, Bern University Hospital; 🇨🇭 Bern, Switzerland

Department of Intensive Care, University Hospital of Wales; 🇬🇧 Cardiff, Wales, United Kingdom

Dept. of Intensive Care, Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands

Dept. of Intensive Care, Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland