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Handling Oxygenation Targets in the Intensive Care Unit

NCT ID: NCT03174002

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2928 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2021-08-03

Brief Summary

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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

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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.

Conditions

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Hypoxemic Respiratory Failure Oxygen Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low oxygenation target

Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge

High oxygenation target

Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge

Interventions

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Oxygen

Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge

Intervention Type DRUG

Oxygen

Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge

Intervention Type DRUG

Other Intervention Names

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Inspired oxygen Inspired oxygen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bodil Steen Rasmussen

Clinical Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bodil Steen Rasmussen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital, Denmark

Anders Perner, MD, PhD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Dept. of Intensive Care, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Dept. of Intensive Care East Section, Øst, Skejby, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Dept. of Intensive Care Section Nord, Skejby, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Dept. of Intensive Care, University Hospital Skejby

Aarhus, , Denmark

Site Status

Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet

Copenhagen, , Denmark

Site Status

Dept. of Intensive Care, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Dept. of Intensive Care, Herlev Hospital

Herlev, , Denmark

Site Status

Dept. of Intensive Care, Herning Hospital

Herning, , Denmark

Site Status

Dept. of Intensive Care, Hillerød Hospital

Hillerød, , Denmark

Site Status

Dept. of Intensive Care, Hjørring Hospital

Hjørring, , Denmark

Site Status

Dept. of Intensive Care, Holbæk Hospital

Holbæk, , Denmark

Site Status

Department of Intensive Care, Holstebro

Holstebro, , Denmark

Site Status

Dept. of Intensive Care, Holstebro Hospital

Holstebro, , Denmark

Site Status

Dept. of Intensive Care, Horsens Hospital

Horsens, , Denmark

Site Status

Dept. of Intensive Care, Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Dept. of Intensive Care, Kolding Hospital

Kolding, , Denmark

Site Status

Dept. of Intensive Care, Køge Hospital

Køge, , Denmark

Site Status

Dept. of Intensive Care, Randers Hospital

Randers, , Denmark

Site Status

Dept. of Intensive Care, Roskilde Hospital

Roskilde, , Denmark

Site Status

Dept. of Intensive Care, Slagelse Hospital

Slagelse, , Denmark

Site Status

Department of Intensive Care, Viborg Hospital

Viborg, , Denmark

Site Status

Dept. of Intensive Care, Helsinki University Hospital

Helsinki, , Finland

Site Status

Dept. of Intensive Care, Central Finland Central Hospital

Jyväskylä, , Finland

Site Status

Dept. of Intensive Care, Kuopio University Hospital, Kuopio

Kuopio, , Finland

Site Status

Dept. of Intensive Care, Turku University Hospital, Turku

Turku, , Finland

Site Status

Dept. of Intensive Care, Landspitali University Hospital Reykjavik

Reykjavik, , Iceland

Site Status

Dept. of Intensive Care, University Medical Center Groningen

Groningen, , Netherlands

Site Status

Dept. of Intensive Care, Canisius Wilhelmina Hospital

Nijmegen, , Netherlands

Site Status

Dept. of Intensive Care, National Hospital, University of Oslo

Oslo, , Norway

Site Status

Dept. of Intensive Care, Basel University Hospital

Basel, , Switzerland

Site Status

Dept. of Intensive Care, Bern University Hospital

Bern, , Switzerland

Site Status

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, United Kingdom

Site Status

Department of Intensive Care, University Hospital of Wales

Cardiff, Wales, United Kingdom

Site Status

Kingston Hospital NHS Foundation Trust

Kingston upon Thames, , United Kingdom

Site Status

Royal Glamorgan Hospital

Llantrisant, , United Kingdom

Site Status

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Wythenshawe Hospital

Manchester, , United Kingdom

Site Status

Countries

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Denmark Finland Iceland Netherlands Norway Switzerland United Kingdom

References

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Barbateskovic M, Schjorring 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):CD012631. doi: 10.1002/14651858.CD012631.pub2.

Reference Type BACKGROUND
PMID: 31773728 (View on PubMed)

Rasmussen BS, Perner A, Wetterslev J, Meyhoff CS, Schjorring 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. No abstract available.

Reference Type BACKGROUND
PMID: 30527413 (View on PubMed)

Schjorring 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.

Reference Type BACKGROUND
PMID: 30883686 (View on PubMed)

Barbateskovic M, Schjorring 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.

Reference Type BACKGROUND
PMID: 29708586 (View on PubMed)

Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Morgan M, Backlund 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.

Reference Type BACKGROUND
PMID: 32068884 (View on PubMed)

Nielsen MB, Klitgaard TL, Weinreich UM, Nielsen FM, Perner A, Schjorring OL, Rasmussen BS. Effects of a lower versus a higher oxygenation target in intensive care unit patients with chronic obstructive pulmonary disease and acute hypoxaemic respiratory failure: a subgroup analysis of a randomised clinical trial. BJA Open. 2024 Apr 29;10:100281. doi: 10.1016/j.bjao.2024.100281. eCollection 2024 Jun.

Reference Type DERIVED
PMID: 38711834 (View on PubMed)

Klitgaard TL, Schjorring OL, Severinsen MT, Perner A, Rasmussen BS. Lower versus higher oxygenation targets in ICU patients with haematological malignancy - insights from the HOT-ICU trial. BJA Open. 2022 Sep 23;4:100090. doi: 10.1016/j.bjao.2022.100090. eCollection 2022 Dec.

Reference Type DERIVED
PMID: 37588787 (View on PubMed)

Crescioli E, Lass Klitgaard T, Perner A, Lilleholt Schjorring O, Steen Rasmussen B. Lower versus higher oxygenation targets in hypoxaemic ICU patients after cardiac arrest. Resuscitation. 2023 Jul;188:109838. doi: 10.1016/j.resuscitation.2023.109838. Epub 2023 May 16.

Reference Type DERIVED
PMID: 37196799 (View on PubMed)

Crescioli E, Klitgaard TL, Poulsen LM, Brand BA, Siegemund M, Grofte T, Keus F, Pedersen UG, Backlund M, Karttunen J, Morgan M, Ciubotariu A, Bunzel AG, Vestergaard SR, Jensen NM, Jensen TS, Kjaer MN, Jensen AKG, Lange T, Wetterslev J, Perner A, Schjorring OL, Rasmussen BS. Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia. Intensive Care Med. 2022 Jun;48(6):714-722. doi: 10.1007/s00134-022-06695-0. Epub 2022 Apr 20.

Reference Type DERIVED
PMID: 35441849 (View on PubMed)

Klitgaard TL, Schjorring OL, Lange T, Moller MH, Perner A, Rasmussen BS, Granholm A. Lower versus higher oxygenation targets in critically ill patients with severe hypoxaemia: secondary Bayesian analysis to explore heterogeneous treatment effects in the Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial. Br J Anaesth. 2022 Jan;128(1):55-64. doi: 10.1016/j.bja.2021.09.010. Epub 2021 Oct 19.

Reference Type DERIVED
PMID: 34674834 (View on PubMed)

Rasmussen BS, Klitgaard TL, Perner A, Brand BA, Hildebrandt T, Siegemund M, Hollinger A, Aagaard SR, Bestle MH, Marcussen KV, Brochner AC, Solling CG, Poulsen LM, Laake JH, Aslam TN, Backlund M, Okkonen M, Morgan M, Sharman M, Lange T, Wetterslev J, Schjorring OL. Oxygenation targets in ICU patients with COVID-19: A post hoc subgroup analysis of the HOT-ICU trial. Acta Anaesthesiol Scand. 2022 Jan;66(1):76-84. doi: 10.1111/aas.13977. Epub 2021 Sep 20.

Reference Type DERIVED
PMID: 34425016 (View on PubMed)

Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Siegemund M, Backlund M, Keus F, Laake JH, Morgan M, Thormar KM, Rosborg SA, Bisgaard J, Erntgaard AES, Lynnerup AH, Pedersen RL, Crescioli E, Gielstrup TC, Behzadi MT, Poulsen LM, Estrup S, Laigaard JP, Andersen C, Mortensen CB, Brand BA, White J, Jarnvig IL, Moller MH, Quist L, Bestle MH, Schonemann-Lund M, Kamper MK, Hindborg M, Hollinger A, Gebhard CE, Zellweger N, Meyhoff CS, Hjort M, Bech LK, Grofte T, Bundgaard H, Ostergaard LHM, Thyo MA, Hildebrandt T, Uslu B, Solling CG, Moller-Nielsen N, Brochner AC, Borup M, Okkonen M, Dieperink W, Pedersen UG, Andreasen AS, Buus L, Aslam TN, Winding RR, Schefold JC, Thorup SB, Iversen SA, Engstrom J, Kjaer MN, Rasmussen BS; HOT-ICU Investigators. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure. N Engl J Med. 2021 Apr 8;384(14):1301-1311. doi: 10.1056/NEJMoa2032510. Epub 2021 Jan 20.

Reference Type DERIVED
PMID: 33471452 (View on PubMed)

Klitgaard TL, Schjorring OL, Lange T, Moller MH, Perner A, Rasmussen BS, Granholm A. Bayesian and heterogeneity of treatment effect analyses of the HOT-ICU trial-A secondary analysis protocol. Acta Anaesthesiol Scand. 2020 Oct;64(9):1376-1381. doi: 10.1111/aas.13669. Epub 2020 Aug 5.

Reference Type DERIVED
PMID: 32659856 (View on PubMed)

Related Links

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https://www.cric.nu/hot-icu/

Link to the HOT-ICU website

Other Identifiers

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2017-000632-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AAUH-ICU-01

Identifier Type: -

Identifier Source: org_study_id