Acute lung injury secondary to traumatic brain injury
Conditions
Interventions
Magnesium Sulfate Group:Early intravenous magnesium sulfate: initial dose of 2g dissolved in 100mL normal saline, infused within 30 minutes within 8 hours after trauma
maintenance dose of 2g/100mL, administered once daily via intravenous infusion for 5 days. Target serum magnesium concentration: 1.0–1.5 mmol/L (infusion paused if >2.0 mmol/L).
Placebo Group:Placebo: isotonic (100mL) 0.9% normal saline, with identical infusion protocol as the magnesium sulfate group (initial dose of 100mL, maintenance of 100mL/day, once daily for 5 days).
Sponsors
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old; 2. The diagnosis of moderate to severe TBI is clear: The Glasgow Coma Scale (GCS) score at admission is 3 to 12 points, and intracranial injury (such as hematoma, cerebral edema or diffuse axonal injury) is confirmed by head CT/MRI. 3. Be admitted to the hospital within 8 hours after trauma and complete the first intervention; 4. Hemodynamic stability: Systolic blood pressure >=90 mmHg (if vasoactive drugs are used, the dose is <=0.3 µg/kg/min and lactate <5 mmol/L); 5. Obtain an informed consent form signed by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: 1. Any of the following lung conditions existed at the time of enrollment: (1) ARDS had been diagnosed (meeting the 2023 Delphi consensus criteria); (2) There is a clear major aspiration event or highly suspected aspiration lung injury; 2. Severe comorbidities: (1) Chronic renal failure (eGFR1.5 mmol/L); 5. Presence of end-stage disease: CT-confirmed end-stage brain herniation (midline displacement >15 mm+ disappearance of the basal cisterna) or multiple organ failure with SOFA>=14 points; 6. Previous history of active neurodegenerative diseases (Alzheimer's disease, uncontrolled epilepsy), myasthenia gravis, space-occupying brain tumors, or old stroke (=4 points or pulmonary contusion >20%), (2) Rupture of abdominal organs requiring emergency laparotomy, (3) Flail chest, (4) Unstable fractures from emergency spinal surgery, or (5) Pelvic fractures with blood loss >1000 mL; 8. Pregnant or lactating women; 9. Have participated in other interventional clinical trials within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of the 28-day hierarchical composite endpoint event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale Extended (GOS-E);28-day all-cause mortality rate;The incidence rate of acute kidney injury;The incidence rate of epilepsy;Glasgow Coma Scale (GCS);Total hospital stay;Incidence atrial fibrillation;Dynamic changes of electrolytes;Length of stay in the ICU;Dynamic changes of biomarkers; | — |
Countries
China
Contacts
Public ContactXi Hong
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
Outcome results
None listed