REGULATE is the first adequately powered trial to systematically compare these vasopressor strategies in severe TBI. The results are expected to provide an evidence-based foundation for developing individualized vasopressor strategies that can simultaneously optimize cerebral and systemic blood flow, ultimately minimizing secondary brain injury and improving patient outcomes.

The study will employ continuous, multimodal monitoring, including intracranial pressure (ICP), arterial pressure, near-infrared spectroscopy, and advanced cardiac output assessment.

The co-primary outcomes are:

Cerebral Autoregulation: Measured by the area under the curve of the Pressure Reactivity Index (PRx) over 48 hours.

Systemic Hemodynamics: Measured by the area under the curve of cardiac output and effective arterial elastance over 48 hours.

Secondary outcomes include cerebral oxygenation, ICP burden, adverse events, mortality, and neurological recovery at three months.

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