Oxygen supplementation in patients with acute pulmonary failure admitted to the intensive care unit: A clinical trial of two seperate levels of oxygen supplementation during treatment in the intensive care unit

Phase 1

• Conditions: Acute hypoxaemic respiratory failure in patients admitted to the intensive care unit; MedDRA version: 20.0Level: PTClassification code 10001053Term: Acute respiratory failureSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-000632-34-FI
• Lead Sponsor: Department of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-06
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2928

Inclusion Criteria

- Acutely admitted to the intensive care unit AND
- Aged = 18 years AND
- Receive supplemental oxygen with a flow of at least 10 L per minute in an open system or at least an fraction of inspired oxygen of 0.50 in a closed system, including invasive ventilation, non-invasive ventilation or continuous positive airway pressure AND
- Are expected to receive oxygen administration for at least 24 hours in the ICU AND
- Have an arterial line in place
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1312
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1616

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 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.;Secondary Objective: To asses health economic implications of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission. Conducted through a health economic analysis at one year follow-up of the last enrolled patient.;Primary end point(s): Mortality;Timepoint(s) of evaluation of this end point: 90 days post-randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of patients with one or more SAEs in the ICU after randomisation; SAEs are defined as new episode of shock and new episodes of ischemic events including myocardial or intestinal ischaemia or ischemic stroke in the 90-day period<br>- Days alive without the use of respiratory support, renal replacement therapy or circulatory support in the 90-day period<br>- Days alive out of the hospital in the 90-day period<br>- Mortality 1-year after randomisation<br>- Health related quality of life (Euroqual, EQ-5D-5L) 1-year after randomisation.<br>- Cognitive function 1-year after randomisation as assessed using RBANS score in selected sites<br>- A health economic analysis based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses);Timepoint(s) of evaluation of this end point: See E.5.2