2024-518092-62-00招募中3 期
Conservative vs conventional oxygen administration in critically ill patients: effects on ICU mortality. A multicentre randomized open label clinical trial.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
结局指标
主要结局
ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).
ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).
次要结局
- - 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.
研究者
Massimo Girardis
Scientific
Azienda Ospedaliero Universitaria Di Modena
研究点 (12)
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