OBJECTIVES:Traumatic brain injury (TBI) is still a major cause of mortality and morbidity. Recent trials have failed to demonstrate a beneficial outcome from therapeutic treatments such as corticosteroids, hypothermia and hypertonic saline. We investigated the effect of a new hyperosmolar solution based on sodium lactate in controlling raised intracranial pressure (ICP). DESIGN AND SETTING: Prospective open randomized study in an adult ICU. PATIENTS: Thirty-four patients with isolated severe TBI (Glasgow Coma Scale <or= 8) and intracranial hypertension were allocated to receive equally hyperosmolar and isovolumic therapy, consisting of either mannitol or sodium lactate. Rescue therapy by crossover to the alternative treatment was indicated when ICP could not be controlled. The primary endpoint was efficacy in lowering ICP after 4 h, with a secondary endpoint of the percentage of successfully treated episodes of intracranial hypertension. The analysis was performed with both intention-to-treat and actual treatments provided. MEASUREMENTS AND RESULTS: Compared to mannitol, the effect of the lactate solution on ICP was significantly more pronounced (7 vs. 4 mmHg, P = 0.016), more prolonged (fourth-hour-ICP decrease: -5.9 +/- 1 vs. -3.2 +/- 0.9 mmHg, P = 0.009) and more frequently successful (90.4 vs. 70.4%, P = 0.053). CONCLUSION: Acute infusion of a sodium lactate-based hyperosmolar solution is effective in treating intracranial hypertension following traumatic brain injury. This effect is significantly more pronounced than that of an equivalent osmotic load of mannitol. Additionally, in this specific group of patients, long-term outcome was better in terms of GOS in those receiving as compared to mannitol. Larger trials are warranted to confirm our findings.
RCT Entities:
OBJECTIVES:Traumatic brain injury (TBI) is still a major cause of mortality and morbidity. Recent trials have failed to demonstrate a beneficial outcome from therapeutic treatments such as corticosteroids, hypothermia and hypertonic saline. We investigated the effect of a new hyperosmolar solution based on sodium lactate in controlling raised intracranial pressure (ICP). DESIGN AND SETTING: Prospective open randomized study in an adult ICU. PATIENTS: Thirty-four patients with isolated severe TBI (Glasgow Coma Scale <or= 8) and intracranial hypertension were allocated to receive equally hyperosmolar and isovolumic therapy, consisting of either mannitol or sodium lactate. Rescue therapy by crossover to the alternative treatment was indicated when ICP could not be controlled. The primary endpoint was efficacy in lowering ICP after 4 h, with a secondary endpoint of the percentage of successfully treated episodes of intracranial hypertension. The analysis was performed with both intention-to-treat and actual treatments provided. MEASUREMENTS AND RESULTS: Compared to mannitol, the effect of the lactate solution on ICP was significantly more pronounced (7 vs. 4 mmHg, P = 0.016), more prolonged (fourth-hour-ICP decrease: -5.9 +/- 1 vs. -3.2 +/- 0.9 mmHg, P = 0.009) and more frequently successful (90.4 vs. 70.4%, P = 0.053). CONCLUSION: Acute infusion of a sodium lactate-based hyperosmolar solution is effective in treating intracranial hypertension following traumatic brain injury. This effect is significantly more pronounced than that of an equivalent osmotic load of mannitol. Additionally, in this specific group of patients, long-term outcome was better in terms of GOS in those receiving as compared to mannitol. Larger trials are warranted to confirm our findings.
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