High versus Low Blood-Pressure Target in Patients with Septic Shock

High versus Low Blood-Pressure Target in Patients with Septic Shock
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DOI:
10.1056/nejmoa1312173
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发表时间:
2014-04-24
影响因子:
158.5
通讯作者:
Radermacher, Peter
Radermacher, Peter
中科院分区:
医学1区
文献类型:
--
作者:
Asfar, Pierre;Meziani, Ferhat;Radermacher, Peter

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背景生存脓毒症运动建议在脓毒症休克患者初始复苏时,平均动脉压至少为65毫米汞柱。然而,这个血压目标是否比一个更高的目标更有效尚不清楚。方法在一项多中心、开放标签试验中,我们随机分配776例脓毒性休克患者接受复苏,平均动脉压目标为80 ~ 85 mm Hg(高目标组)或65 ~ 70 mm Hg(低目标组)。主要终点为第28天的死亡率。结果28 d时,两组间死亡率无显著差异,388例患者中高目标组有142例(36.6%)死亡,388例患者中低目标组有132例(34.0%)死亡(高目标组的风险比为1.07;95%可信区间[CI]为0.84 ~ 1.38;P = 0.57)。90天死亡率也无显著差异,分别有170例死亡(43.8%)和164例死亡(42.3%)(风险比1.04;95% CI 0.83 ~ 1.30; P = 0.74)。两组严重不良事件的发生率无显著差异(分别为74例[19.1%]和69例[17.8%],P = 0.64)。然而,新诊断心房颤动的发生率在高目标组高于低目标组。在慢性高血压患者中,高目标组的患者比低目标组的患者需要更少的肾脏替代治疗,但这种治疗与死亡率的差异无关。结论:在接受复苏的脓毒性休克患者中,以平均动脉压80 - 85 mm Hg为目标,与65 - 70 mm Hg相比,在28天或90天的死亡率没有显著差异。(由法国卫生部资助;SEPSISPAM ClinicalTrials.gov编号:NCT01149278。)
Background The Surviving Sepsis Campaign recommends targeting a mean arterial pressure of at least 65 mm Hg during initial resuscitation of patients with septic shock. However, whether this blood-pressure target is more or less effective than a higher target is unknown.Methods In a multicenter, open-label trial, we randomly assigned 776 patients with septic shock to undergo resuscitation with a mean arterial pressure target of either 80 to 85 mm Hg (high-target group) or 65 to 70 mm Hg (low-target group). The primary end point was mortality at day 28.Results At 28 days, there was no significant between-group difference in mortality, with deaths reported in 142 of 388 patients in the high-target group (36.6%) and 132 of 388 patients in the low-target group (34.0%) (hazard ratio in the high-target group, 1.07; 95% confidence interval [CI], 0.84 to 1.38; P = 0.57). There was also no significant difference in mortality at 90 days, with 170 deaths (43.8%) and 164 deaths (42.3%), respectively (hazard ratio, 1.04; 95% CI, 0.83 to 1.30; P = 0.74). The occurrence of serious adverse events did not differ significantly between the two groups (74 events [19.1%] and 69 events [17.8%], respectively; P = 0.64). However, the incidence of newly diagnosed atrial fibrillation was higher in the high-target group than in the low-target group. Among patients with chronic hypertension, those in the high-target group required less renal-replacement therapy than did those in the low-target group, but such therapy was not associated with a difference in mortality.Conclusions Targeting a mean arterial pressure of 80 to 85 mm Hg, as compared with 65 to 70 mm Hg, in patients with septic shock undergoing resuscitation did not result in significant differences in mortality at either 28 or 90 days. (Funded by the French Ministry of Health; SEPSISPAM ClinicalTrials.gov number, NCT01149278.)