The International journal of neuroscience · 2013
Clevidipine for acute hypertension in patients with subarachnoid hemorrhage: a pilot study.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Varelas Panayiotis N, Abdelhak Tamer, Corry Jesse J, James Elysia, Rehman Mohammed F, Schultz Lonni, Mays-Wilson Kathleen, Mitsias Panayiotis
Аннотация
PURPOSE: Clevidipine is a novel, ultra-short acting dihydropyridine. We hypothesized that clevidipine would rapidly control elevated blood pressure (BP) in patients with aneurysmal subarachnoid hemorrhage (SAH).
MATERIALS AND METHODS: This prospective open-label pilot study evaluated the efficacy and safety of clevidipine in reducing blood pressure (BP) to a pre-specified range and within 30 min before or after clipping or coiling of the aneurysm.
RESULTS: We enrolled five patients who received eight clevidipine infusions, including 1587 systolic or diastolic BP data points. The mean SBP upper and lower goals were set at 154 and 122 mmHg. The primary end point of achieving SBP control within <30 min was reached in all patients within 14.2 ± 6.4 min at an infusion rate of 10.8 ± 9.1 mg/h. The mean pre-infusion, during infusion and post-infusion SBP measurements were 165.5 ± 2.55, 146.4 ± 2.48 and 159.3 ± 11.5 mmHg ( p < 0.05 for pre- vs infusion comparison), respectively. After reaching the primary end point and during the clevidipine infusion, 17.5% and 11.8% of SBP readings were above the upper and below the lower goals, respectively. No patients re-bled. In one patient, the infusion had to be stopped temporarily three times due to SBP decrease below the lower goal.
CONCLUSION: Clevidipine controlled SBP in all patients with aneurysmal SAH in <22 min and kept it within the elective range 70% of the time without major complications.
MATERIALS AND METHODS: This prospective open-label pilot study evaluated the efficacy and safety of clevidipine in reducing blood pressure (BP) to a pre-specified range and within 30 min before or after clipping or coiling of the aneurysm.
RESULTS: We enrolled five patients who received eight clevidipine infusions, including 1587 systolic or diastolic BP data points. The mean SBP upper and lower goals were set at 154 and 122 mmHg. The primary end point of achieving SBP control within <30 min was reached in all patients within 14.2 ± 6.4 min at an infusion rate of 10.8 ± 9.1 mg/h. The mean pre-infusion, during infusion and post-infusion SBP measurements were 165.5 ± 2.55, 146.4 ± 2.48 and 159.3 ± 11.5 mmHg ( p < 0.05 for pre- vs infusion comparison), respectively. After reaching the primary end point and during the clevidipine infusion, 17.5% and 11.8% of SBP readings were above the upper and below the lower goals, respectively. No patients re-bled. In one patient, the infusion had to be stopped temporarily three times due to SBP decrease below the lower goal.
CONCLUSION: Clevidipine controlled SBP in all patients with aneurysmal SAH in <22 min and kept it within the elective range 70% of the time without major complications.