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

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ClinicalTrials.gov Identifier: NCT03174002
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Bodil Steen Rasmussen, 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.

Condition or disease Intervention/treatment Phase
Hypoxemic Respiratory Failure Oxygen Toxicity Drug: Oxygen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2928 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : November 3, 2020
Estimated Study Completion Date : November 3, 2020


Arm Intervention/treatment
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 Name: 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 12 kPa (90 mmHg) from ICU admission to ICU discharge
Other Name: Inspired oxygen




Primary Outcome Measures :
  1. 90-days mortality [ Time Frame: 90 days ]
    Landmark mortality 90-days after randomisation


Secondary Outcome Measures :
  1. 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

  2. Days alive out of the hospital [ Time Frame: Within 90 days ]
    Percentage of days alive out of the hospital

  3. 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

  4. 1-year mortality [ Time Frame: 1 year ]
    Landmark mortality 1 year after randomisation

  5. 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

  6. 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

  7. Pulmonary function [ Time Frame: 1 year ]
    Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites

  8. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174002


Locations
Show Show 37 study locations
Sponsors and Collaborators
Aalborg University Hospital
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
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Principal Investigator: Bodil Steen Rasmussen, MD, PhD Aalborg University Hospital, Denmark
Study Chair: Anders Perner, MD, PhD Rigshospitalet, Denmark
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bodil Steen Rasmussen, Clinical Professor, MD, PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03174002    
Other Study ID Numbers: AAUH-ICU-01
2017-000632-34 ( EudraCT Number )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Study Protocol and Statistical Analysis Plan has been published. Informed Consent Form are available on the webpage (www.cric.nu/hot-icu)
Access Criteria: Managed by the Steering Committee of the HOT-ICUT trial.
URL: https://www.cric.nu/hot-icu/

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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
Keywords provided by Bodil Steen Rasmussen, Aalborg University Hospital:
Oxygenation
Acute Respiratory Distress Syndrome
Mechanical ventilation
Critical illness
Critical care
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases