Clinical trial NCT06548802: Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Official title: Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pulmonary Injury After Intracerebral Hemorrhage
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Fujian Medical University
First posted: 2024-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The objective of this study was to evaluate the efficacy and safety of baricitinib in patients with pulmonary injury after intracerebral hemorrhage.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients ≥ 18 years old;
2. 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.
3. 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;
4. There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease.
5. Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Exclusion Criteria:

1. Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death;
2. Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery;
3. Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials;
4. 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;
5. Venous thromboembolism or risk of thrombosis;
6. Life expectancy after enrollment ≤24h.

Primary outcomes:
measure: Recovery time
timeFrame: From day 1 to day 30 after the lung injury occurrence.
Secondary outcomes:
measure: Hematoma volume after intracerebral hemorrhage
timeFrame: At 1, 14, and 90 days after diagnosis.
measure: NIHSS score
timeFrame: At 1, 3, 7, 14, 30 and 90 days after diagnosis.
measure: mRS score
timeFrame: At 90 days after diagnosis.
measure: Severity score
timeFrame: At 1, 3, 7, 14, 30 days after diagnosis.
measure: Murray's lung injury score
timeFrame: At 1, 3, 7, 14 days after diagnosis.
measure: Days without ventilator support
timeFrame: From diagnosis to 30 days.
measure: Length of ICU stay
timeFrame: From diagnosis to 30 days.
measure: APACHEⅡ score
timeFrame: At 1, 14, 30 days after diagnosis.
measure: Total hospitalization days
timeFrame: From diagnosis to 90 days.
measure: Mortality
timeFrame: At 14, 30 and 90 days after diagnosis.
measure: Incidence of treatment-emergent adverse events [safety and tolerability
timeFrame: From diagnosis to 90 days.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References: