Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Baricitinib
DrugBaricitinib was given 4mg once daily, with the first dose taken within 24 hours of the appearance of lung injury and continued for 14 days.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard treatment plus BaricitinibExperimental treatment 1 intervention
Group B: Standard treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recovery time
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.
Time frame
From day 1 to day 30 after the lung injury occurrence.Secondary outcomes
1
Hematoma volume after intracerebral hemorrhage
1. CT images of the head were obtained at 1, 14, and 90 days after diagnosis. CT scan within 24 hours after diagnosis was used as the baseline analysis. 2. If the patient is discharged from the hospital, a CT scan of the head should be performed on the 90th day if conditions permit.
Time frame
At 1, 14, and 90 days after diagnosis.2
NIHSS score
Assessed according to the National Institutes of Health Stroke Scale (NIHSS), the score ranges from 0 (asymptomatic) to 42 (death).
Time frame
At 1, 3, 7, 14, 30 and 90 days after diagnosis.3
mRS score
Assessed by mRS Score on a scale of 0 (asymptomatic) to 6 (dead).
Time frame
At 90 days after diagnosis.4
Severity score
Assessed by score on a scale of 0 (asymptomatic) to 8 (dead). Scores were depended on the treatment needed (Nasal tube = 1, mask = 1, non-invasive positive pressure ventilation = 1, trachea cannula = 1, glucocorticoids treatment =1, prone position ventilation = 1, ECMO= 1, death = 1.)
Time frame
At 1, 3, 7, 14, 30 days after diagnosis.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tianjin Medical University General Hospital
Lead sponsor
First Affiliated Hospital of Fujian Medical University
Collaborator
Source ClinicalTrials.gov