Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Some patients with intracerebral hemorrhage will develop severe lung injury such as respiratory distress syndrome. Baricitinib has been approved by the FDA for severe pneumonia caused by the coronavirus, and has been used in the treatment of hospitalized patients with COVID-19. Baricitinib significantly reduced the risk of death and shortened the length of stay in COVID-19 patients. According to clinical observations, there was no significant increase in deaths or infections due to non-COVID-19 causes during recovery, nor was there a significant increase in thrombosis. Excessive inflammatory factors release can cause inflammatory storms that damage lung cells, lead to lung injury, and eventually lead to respiratory failure, respiratory distress syndrome and other conditions, endangering life safety. Studies have shown that Baricitinib can inhibit the production of excessive pro-inflammatory cytokines by lung macrophages through the JAK pathway and reduce lung injury caused by inflammatory storms. Therefore, in patients with acute stroke with lung infection or severe lung injury, short-term use of baricitinib will help to reduce lung injury and promote the recovery of neurological function, and shorten the length of hospital stay. However, there is currently a lack of effective clinical evidence of baricitinib in the treatment of lung injury after intracerebral hemorrhage, and further research is needed.
详细描述
The objective of this study was to evaluate the efficacy and safety of baricitinib in patients with pulmonary injury after intracerebral hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years old;
- •The diagnosis was non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage (including supratentorial deep hemorrhage, lobal hemorrhage, cerebellar hemorrhage, brainstem hemorrhage, intracerebral hemorrhage, intracerebral parenchymal hemorrhage into ventricle, subarachnoid hemorrhage), which was confirmed by CT scan.
- •Onset of ARDS within 48 hours to 7 days after admission (as defined by Berlin) : ① Patients with moderate to severe ARDS symptoms or progressive dyspnea within 7 days (100mmHg < PaO2/FiO2≤200, PEEP≥5cmH2O); ② Hypoxemia: SpO2/FiO2≤315mmHg and SpO2≤97%, and could not be explained by acute heart failure and fluid overload; ③ Need intubation or mechanical ventilation; ④ Imaging findings (chest X-ray/chest CT) : infiltration of both lungs, cannot be completely explained by pleural effusion, lobar/whole lung atelectasis and nodule;
- •There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease.
- •Able and willing to sign written informed consent and comply with the requirements of the research protocol.
排除标准
- •Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death;
- •Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery;
- •Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials;
- •Combine the following cases that are not eligible to participate in this study: ① Severe hepatic insufficiency (ALT/AST > 5xULN); ② Moderate to severe renal insufficiency (eGFR < 60ml/min/1.73m2); ③ Undergoing hemodialysis or hemofiltration; ④ Neutrophils or lymphocytes decreased (Absolute neutrophil count < 1000/ul, absolute lymphocyte count < 200/ul); ⑤ During pregnancy or childbirth;
- •Venous thromboembolism or risk of thrombosis;
- •Life expectancy after enrollment ≤24h.
研究组 & 干预措施
Standard treatment plus Baricitinib
On standard treatment, Baricitinib was given 4mg once daily, with the first dose taken within 24 hours of the appearance of lung injury and continued for 14 days.
干预措施: Baricitinib (Drug)
结局指标
主要结局
Recovery time
时间窗: From day 1 to day 30 after the lung injury occurrence.
1. If the patient only required oxygen inhalation with the mask, SpO2≥97% of days without the mask were observed. 2. If the patient has a tracheal intubation and ventilator-assisted breathing, observe the days needed for the patient to be removed from the ventilator.
次要结局
- mRS score(At 90 days after diagnosis.)
- Murray's lung injury score(At 1, 3, 7, 14 days after diagnosis.)
- Hematoma volume after intracerebral hemorrhage(At 1, 14, and 90 days after diagnosis.)
- NIHSS score(At 1, 3, 7, 14, 30 and 90 days after diagnosis.)
- Severity score(At 1, 3, 7, 14, 30 days after diagnosis.)
- Days without ventilator support(From diagnosis to 30 days.)
- Length of ICU stay(From diagnosis to 30 days.)
- APACHEⅡ score(At 1, 14, 30 days after diagnosis.)
- Total hospitalization days(From diagnosis to 90 days.)
- Mortality(At 14, 30 and 90 days after diagnosis.)
- Incidence of treatment-emergent adverse events [safety and tolerability(From diagnosis to 90 days.)
研究者
Qiang Liu
Professor of Department of Neurology
Tianjin Medical University General Hospital