Effect of continuous infusion of hypertonic saline vs standard care on 6-month neurological outcomes in patients with traumatic brain injury: the COBI randomized clinical trial
Roquilly A, Moyer JD, Huet O, et al. JAMA. 2021;325(20):2056-2066.
Hypertonic saline is frequently used or at least discussed for cases of traumatic brain injury (TBI) and intracranial hemorrhage (ICH) when cerebral edema and potential herniation are concerns.
The Continuous Hyperosmolar Therapy for Traumatic Brain-Injured Patients (COBI) trial is a multicenter, open-label, randomized trial from France comparing a 20% hypertonic saline solution to usual care in patients with moderate to severe TBI.
The cohort of interest was defined as adults with a Glasgow Coma Scale score ≤12 and evidence of injury on head CT.
Patients in the intervention arm received an initial bolus of hypertonic saline and then were started on a drip of 20% hypertonic saline titrated to keep the serum sodium between 140 and 155 mmol/L.
If patients had evidence of ICH, regardless of the treatment arm, they received hyperosmolar therapy (a bolus of mannitol or hypertonic saline) or decompressive craniectomy as part of the standard treatment.
The primary outcome was the Glasgow Outcome Scale–Extended (GOS-E) score at 6 months (8-point scale with lower scores indicating worse outcomes).
Patients were randomized, and 370 patients were followed up. Primary outcomes were unavailable for 11 patients.
The baseline characteristics were similar, with a median age in the 40s, a median Glasgow Coma Scale score of 7, and an approximately 70% rate of bilateral reactive pupils.
At 6 months, no difference in GOS-E scores was observed between groups (OR 1.02).
Multiple secondary outcomes, including the rates of other interventions, ICU length of stay, 6-month mortality, and proportion of patients with good neurologic outcomes, were statistically similar between groups.
The risk of intracranial hypertension was lower in the active treatment arm for 2 days, but a rebound effect was seen in this group from day 4 onward.
Although concerns exist regarding the use of hypertonic saline in terms of kidney toxicity and thrombotic events, among others, these effects were not observed at elevated rates in this trial.
EMA 2021 SeptemberFull episode audio for MD edition187:33 min - 182 MB - M4AEMA 2021 September - All Abstracts550 KB - PDFEMA 2021 September - MP3s225 MB - ZIPTime To Talk A Little Nerdy: Subgroup Analysis518 KB - PDF
To earn CME for this chapter, you need to subscribe.