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.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Mortality 90 days after randomisation.
Secondary outcome
Secondary outcomes: serious adverse events in the ICU, days alive without organ
support and days alive out of hospital in the 90-day period, and mortality,
health-related quality of life, cognitive function and a health economic
analysis at 1-year after randomisation.
Background summary
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.
Study objective
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 design
We will conduct an investigator-initiated, pragmatic, outcome assessment
blinded, international, multicentre, randomised parallel-group trial of two
targets of PaO2.
Intervention
Oxygen administered to achieve a PaO2 target of 8 kPa (60 mmHg) or a PaO2
target of 12 kPa (90 mmHg) during ICU stay for a maximum of 90 days.
Study burden and risks
Since supplementary oxygen is a well-established intervention and the two
targets of PaO2 are within the presently recommended ranges there will be no
additional risk for patients included in the HOT-ICU trial. None of the
oxygenation strategies are proven the best, and clinical practices vary widely
Likewise, any benefits or harms in either arm cannot be known with the present
available evidence and needs to be elucidated in the setting of a large RCT.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-000632-34-NL |
| ClinicalTrials.gov | NCT03174002 |
| CCMO | NL62452.042.17 |