Handling Oxygenation Targets in the Intensive Care Unit

• Register: ClinicalTrials.gov
• Last refreshed on: 1 November 2021
• Main ID: NCT03174002
• Date of registration: 30/05/2017
• Prospective Registration: Yes
• Primary sponsor: Aalborg University Hospital
• Public title: Handling Oxygenation Targets in the Intensive Care Unit HOT-ICU
• Scientific 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
• Date of first enrolment: June 19, 2017
• Target sample size: 2928
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03174002
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Anders Perner, MD, PhD
• Affiliation: Rigshospitalet, Denmark

• Name: Bodil Steen Rasmussen, MD, PhD
• Affiliation: Aalborg University Hospital, Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypoxemic Respiratory Failure

Oxygen Toxicity

Intervention(s)

Drug: Oxygen

Primary Outcome(s)

90-days mortality [Time Frame: 90 days]

Secondary Outcome(s)

Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites [Time Frame: 1 year]

1-year mortality [Time Frame: 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]

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

Days alive without organ support [Time Frame: Within 90 days]

Pulmonary function [Time Frame: 1 year]

A health economic analysis [Time Frame: 90 days]

Number of patients with one or more serious adverse events [Time Frame: Until ICU discharge, maximum 90 days]

Secondary ID(s)

2017-000632-34

AAUH-ICU-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Rigshospitalet, Denmark

Copenhagen Trial Unit, Center for Clinical Intervention Research