Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)

October 24, 2021 updated by: Bodil Steen Rasmussen, Aalborg University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2928

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Dept. of Intensive Care, Aalborg University Hospital
      • Aarhus, Denmark, 8000
        • Dept. of Intensive Care East Section, Øst, Skejby, Aarhus University Hospital
      • Aarhus, Denmark, 8000
        • Dept. of Intensive Care Section Nord, Skejby, Aarhus University Hospital
      • Aarhus, Denmark, 8200
        • Dept. of Intensive Care, University Hospital Skejby
      • Copenhagen, Denmark, 2100
        • Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
      • Copenhagen, Denmark, 2400
        • Dept. of Intensive Care, Bispebjerg Hospital
      • Herlev, Denmark, 2730
        • Dept. of Intensive Care, Herlev Hospital
      • Herning, Denmark, 7400
        • Dept. of Intensive Care, Herning Hospital
      • Hillerød, Denmark, 3400
        • Dept. of Intensive Care, Hillerød Hospital
      • Hjørring, Denmark, 9800
        • Dept. of Intensive Care, Hjørring Hospital
      • Holbæk, Denmark, 4300
        • Dept. of Intensive Care, Holbæk Hospital
      • Holstebro, Denmark, 7500
        • Department of Intensive Care, Holstebro
      • Holstebro, Denmark, 7500
        • Dept. of Intensive Care, Holstebro Hospital
      • Horsens, Denmark, 8700
        • Dept. of Intensive Care, Horsens Hospital
      • Hvidovre, Denmark, 2650
        • Dept. of Intensive care, Hvidovre Hospital
      • Kolding, Denmark, 6000
        • Dept. of Intensive Care, Kolding Hospital
      • Køge, Denmark, 4600
        • Dept. of Intensive Care, Køge Hospital
      • Randers, Denmark, 8930
        • Dept. of Intensive Care, Randers Hospital
      • Roskilde, Denmark, 4000
        • Dept. of Intensive Care, Roskilde Hospital
      • Slagelse, Denmark, 4200
        • Dept. of Intensive Care, Slagelse Hospital
      • Viborg, Denmark, 8800
        • Department of Intensive Care, Viborg Hospital
  • Finland
      • Helsinki, Finland
        • Dept. of Intensive Care, Helsinki University Hospital
      • Jyväskylä, Finland, 40620
        • Dept. of Intensive Care, Central Finland Central Hospital
      • Kuopio, Finland, 70210
        • Dept. of Intensive Care, Kuopio University Hospital, Kuopio
      • Turku, Finland, 20520
        • Dept. of Intensive Care, Turku University Hospital, Turku
  • Iceland
      • Reykjavík, Iceland
        • Dept. of Intensive Care, Landspitali University Hospital Reykjavik
  • Netherlands
      • Groningen, Netherlands, 9713
        • Dept. of Intensive Care, University Medical Center Groningen
      • Nijmegen, Netherlands, 6532 SZ
        • Dept. of Intensive Care, Canisius Wilhelmina Hospital
  • Norway
      • Oslo, Norway
        • Dept. of Intensive Care, National Hospital, University of Oslo
  • Switzerland
      • Basel, Switzerland, 4056
        • Dept. of Intensive Care, Basel University Hospital
      • Bern, Switzerland, 3010
        • Dept. of Intensive Care, Bern University Hospital
  • United Kingdom
      • Kingston Upon Thames, United Kingdom, KT2 7QB
        • Kingston Hospital NHS Foundation Trust
      • Llantrisant, United Kingdom, CF72 8XR
        • Royal Glamorgan Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Royal Berkshire NHS Foundation Trust
    • Wales
      • Cardiff, Wales, United Kingdom
        • Department of Intensive Care, University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low oxygenation target
Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)
Drug: Oxygen
Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
Other Names:
  • Inspired oxygen
Drug: Oxygen
Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
Other Names:
  • Inspired oxygen
Active Comparator: High oxygenation target
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
Other Names:
  • Inspired oxygen
Drug: Oxygen
Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
Other Names:
  • Inspired oxygen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
90-days mortality
Time Frame: 90 days
Landmark mortality 90-days after randomisation
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days alive without organ support
Time Frame: Within 90 days
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Within 90 days
Days alive out of the hospital
Time Frame: Within 90 days
Percentage of days alive out of the hospital
Within 90 days
Number of patients with one or more serious adverse events
Time Frame: 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
Until ICU discharge, maximum 90 days
1-year mortality
Time Frame: 1 year
Landmark mortality 1 year after randomisation
1 year
Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites
Time Frame: 1 year
EQ-5D-5L 1-year after randomisation
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
Time Frame: 1 year
RBANS score 1 year after randomisation at selected sites
1 year
Pulmonary function
Time Frame: 1 year
Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites
1 year
A health economic analysis
Time Frame: 90 days
The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anders Perner, MD, PhD, Rigshospitalet, Denmark
  • Principal Investigator: Bodil Steen Rasmussen, MD, PhD, Aalborg University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAUH-ICU-01
  • 2017-000632-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Study Protocol and Statistical Analysis Plan has been published. Informed Consent Form are available on the webpage (www.cric.nu/hot-icu)

IPD Sharing Access Criteria

Managed by the Steering Committee of the HOT-ICUT trial.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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