COBI Trial Summary: Hypertonic Saline in Traumatic Brain Injury

COBI trial hypertonic saline

2021 COBI TRIAL M Effect of continuous infusion of hypertonic saline vs standard care on 6-month neurological outcomes in patients with traumatic brain injury multicenter, parallel-group, open-label, randomized clinical trial Objective: To assess whether continuous infusion of 20% hypertonic saline solution improves neurological outcome at 6 months in patients with moderate to severe TBI. 5 370 patients Inclusion criteria: Participants of age 18-80 years: -admitted to ICU with moderate to severe TBI (GCS <12) -Positive CT findings (EDH, SDH, SAH, brain contusion, brain haematoma, cerebral edema or skull fracture) Continuous infusion group (n=185) Control group (n=185) PRIMARY OUTCOME GOS-E score at 6 months OR 1.02; 95% CI, 0.71 to 1.47; P=0.92 No significant difference SECONDARY OUTCOME 33.7 Intracranial hypertension episodes % OR 0.80; 95% CI, 0.51 to 1.26 36.3 Severe adverse events % 24.9 Conclusion: Among patients with moderate to severe traumatic brain injury, treatment with continuous infusion of 20% hypertonic saline compared with standard care did not result in a significantly better neurological status at 6 months. A. Roquilly et al. JAMA 2021;325(20) 2056-2066