2024-519759-27-00招募中4 期
Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 980
- 试验地点
- 11
- 主要终点
- All-cause hospital mortality.
研究概览
简要总结
The effects 20/10 mg vs. 6 mg of intravenous dexamethasone on the number of deaths at 60 days after randomization and the number of days alive without ventilator support at 28 days, and other subjectcentered outcomes in adult subjects with AHRF (including ARDS) caused by pulmonary or systemic infections (including COVID-19). Death from any cause 60 days after randomization. Death, if occurred, will be recorded irrespective whether the subject remains in the same hospital, in another health care facility, or discharged home. If subjects are discharged alive from hospital before day 60, clinical status information at 60 days will be obtained from the electronic clinical record.
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
- •Age ≥18 years.
- •Intubated and mechanically ventilated, defined as requiring ventilatory support at the time of Screening.
- •Acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.
- •ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO
- •Pulmonary or systemic infectious etiology of AHRF.
排除标准
- •Subjects with a known contraindication to corticosteroids or know hypersensitivity. History of any hypersensitivity reaction to dexamethasone, including but not limited to urticaria, eczema, angioedema, bronchospasm, and anaphylaxis.
- •Subjects who have an indication of chronic use of higher doses of systemic corticosteroids. Use of systemic corticosteroids in doses higher than 6 mg dexamethasone equivalents for other indications than COVID- 19: systemic corticosteroids in doses higher than 6 mg dexamethasone / 6 mg betamethasone / 200 mg cortisone / 160 mg hydrocortisone / 32 mg methylprednisolone / 40 mg prednisolone / 40 mg prednisone.
- •Subjects who have received corticosteroids for 5 consecutive days or more up to the day of screening.
- •Pregnant woman.
- •Participation in another therapeutic trial study that collide.
- •Lack of informed consent.
结局指标
主要结局
All-cause hospital mortality.
All-cause hospital mortality.
次要结局
- Proportions with viral RNA detection over time.
- Number of ventilator free-days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated >=28 days and for subjects who die, VFD is 0.
- Mortality at ICU and at Day 28.
- Duration (in days) on mechanical ventilation.
- Length of stay (in days) in the hospital for survivors.
- Time (in days) from treatment initiation to death.
研究者
Projects Department
Scientific
Consorcio Centro De Investigacion Biomedica En Red
研究点 (11)
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