Conservative vs conventional oxygen administration in critically ill patients: effects on ICU mortality. A multicentre randomized open label clinical trial.

Azienda Ospedaliero Universitaria Di Modena12 sites in 1 country1,000 target enrollmentDecember 9, 2024

DrugsOXYGEN DINITROGENII OXIDUM OXYGENIUM NITROGEN MONOXIDE NITROGEN DIOXIDE LAUGHING GAS

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Azienda Ospedaliero Universitaria Di Modena
Enrollment: 1000
Locations: 12
Primary Endpoint: ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To verify the hypothesis that strict maintenance of normoxia improves survival in a wide population of mechanically ventilated critically ill patients compared to the application of conventional more liberal strategies of oxygen administration. Survival will be measured at ICU discharge.

Registry

euclinicaltrials.eu

Start Date

December 9, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Azienda Ospedaliero Universitaria Di Modena

Responsible Party

Principal Investigator

Massimo Girardis

Scientific

Azienda Ospedaliero Universitaria Di Modena

Eligibility Criteria

Inclusion Criteria

•Critically ill patients admitted to participant ICUs, - Age ≥ 18 years without regards about sex and ethnicity; - Expected length of ICU stay of more than 72 hours. - Need of any respiratory support (IMV or NIMV) at admission and with an expected length of respiratory support ≥ 6 hours - Acquisition of informed consent.

Exclusion Criteria

•Pregnancy: Patients who are known to be pregnant or with a positive serum pregnancy test will be excluded. All potentially fertile females will be tested for pregnancy before enrolment in the study. We will consider as potentially fertile all female patients between 18 and 55 with no documented evidence of menopause, hysterectomy, surgical sterilization. - Admission to ICU after elective surgery - ICU readmission (after a first discharge) in the study period; - IMV or NIMV greater than 12 hours in the 28 days before study inclusion; - Clinical decision to withhold life-sustaining treatment or “too sick to benefit” or patients with a life expectancy of less than 28 days due to a chronic or underlying medical condition. - Previous enrolment in other interventional studies of targeted oxygen therapy; - Acute respiratory failure on chronic obstructive pulmonary disease - Acute respiratory distress syndrome (ARDS) with a PaO2/FiO2 ratio <
•Long-term supplemental oxygen therapy. - Patients candidate to hyperoxia treatment for reasons including (but not limited to) carbon monoxide poisoning or to hyperbaric oxygen therapy;

Outcomes

Primary Outcomes

ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).

Secondary Outcomes

- 90-day mortality, - The occurrence of new organ dysfunction defined as a SOFA score ≥3 for the corresponding organ, occurring ≥48 hours after ICU admission, - bloodstream, respiratory and surgical site infections, - VFHs during the ICU stay, - VasoFHs during the ICU stay, - ICU free days at 28-day and at 90-day, - Cognitive Dysfunction at ICU discharge (censored at 90 days) by MMSE, - ICU acquired weakness at ICU discharge (censored at 90 days) by MRC Scale.