Early Continuous Infusion of Hypertonic Saline Solution Compared to Standard Care to Improve Neurological Outcomes in Adults with Traumatic Brain Injury

What this Trial Is About

Researchers are evaluating the effectiveness of early continuous intravenous infusion of hypertonic saline solution HSS to improve survival and daily life independence at 6 months in adults with traumatic brain injury TBI who are at high risk of intracranial hypertension. This phase 3 randomized trial compares HSS infusion with standard care to assess neurological outcomes and treatment impact. Participants receive either a continuous infusion of HSS 20% sodium chloride for 48 hours, which may be extended if intracranial hypertension persists, or standard care without HSS infusion. The study uses a parallel design with triple masking to evaluate the effects of early HSS treatment on TBI patients admitted to intensive care units. During the study, participants are closely monitored for intracranial pressure and neurological recovery through various assessments including neurological outcome measures at 3 and 6 months, quality of life evaluations up to 12 months, amnesia and cognitive function tests, and tolerance monitoring for one month. Genetic biomarker analysis and cost-effectiveness are also assessed over 12 months. The study includes detailed follow-up to measure treatment efficacy and safety over time.

Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.