Hypertonic saline no better than standard care for improving outcomes in TBI patients: JAMA
France: Treatment with continuous infusion of 20% hypertonic saline of no benefit over standard care for significantly improving neurological status at 6 months in patients with moderate to severe traumatic brain injury (TBI), finds a recent study in JAMA.
Fluid therapy is an important component for the prevention and treatment of secondary brain injuries. However, it is not clear whether it modulates clinical outcomes. To determine the same, Antoine Roquilly, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France, and colleagues aimed to determine whether a continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.
For this purpose, the researchers conducted a multicenter randomized clinical trial in 9 intensive care units in France. It included 370 patients with moderate to severe traumatic brain injury; out of which 359 (97%) completed the trial.
Patients were randomized to receive either continuous infusion of 20% hypertonic saline solution plus standard care (n = 185) or standard care alone (controls; n = 185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.
The primary outcome was Extended Glasgow Outcome Scale (GOS-E) score (range, 1-8, with lower scores indicating worse functional outcome) at 6 months, obtained centrally by blinded assessors and analyzed with ordinal logistic regression adjusted for prespecified prognostic factors (with a common odds ratio [OR] >1.0 favoring intervention).
Key findings of the study include:
- The adjusted common OR for the GOS-E score at 6 months was 1.02.
- Of the 12 secondary outcomes, 10 were not significantly different.
- Intracranial hypertension developed in 33.7% patients in the intervention group and 36.3% patients in the control group (absolute difference, −2.6%; OR, 0.80).
- There was no significant difference in 6-month mortality (15.9% in the intervention group vs 20.8% in the control group; absolute difference, −4.9%; hazard ratio, 0.79).
"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," wrote the authors. "However, confidence intervals for the findings were wide, and the study may have had limited power to detect a clinically important difference."
The study titled, "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," is published in JAMA.