RESUMEN
STUDY OBJECTIVE: To evaluate the pharmacokinetics of high-dose methylprednisolone in patients with acute spinal cord injury (ASCI). DESIGN: Open-label study of consecutive patients with ASCI, and retrospective review of able-bodied controls. SETTING: Emergency Medicine Department of a large, urban, university-affiliated, tertiary care trauma center. PATIENTS: Eleven men with ASCI. INTERVENTIONS: Methylprednisolone sodium succinate 30 mg/kg intravenous bolus, followed by 5.4 mg/kg/hour for 23 hours, administered according to the second National Acute Spinal Cord Injury Study (NASCIS 2) protocol. MEASUREMENTS AND MAIN RESULTS: The total systemic clearance of methylprednisolone was significantly less in acutely injured patients (mean +/- SD 30.04 +/- 12.03 L/hr) than in historically reported able-bodied controls (44.70 +/- 4.90 L/hr). An inverse correlation between the neurologic level of injury and systemic clearance was seen. No differences in volume of distribution were discernible between patients (126.90 L) and controls (135.45 L). CONCLUSION: Patients with acute spinal cord injury administered methylprednisolone according to the NASCIS 2 protocol had an apparent decrease in total systemic clearance of the drug without a commensurate change in volume of distribution. Additional studies are warranted to confirm these findings and assess the potential impact of diminished clearance on the efficacy of the agent in ASCI.