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脓毒性休克患儿中“间歇性”与“连续性”中心静脉血氧饱和度监测:一项随机非劣效性试验

'Intermittent' versus 'continuous' ScvO monitoring in children with septic shock: a randomised, non-inferiority trial.

作者信息

Sankar Jhuma, Singh Man, Kumar Kiran, Sankar M Jeeva, Kabra Sushil Kumar, Lodha Rakesh

机构信息

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Intensive Care Med. 2020 Jan;46(1):82-92. doi: 10.1007/s00134-019-05858-w. Epub 2019 Nov 28.

Abstract

PURPOSE

To compare the effect of 'intermittent' central venous oxygen saturation (ScvO) monitoring with 'continuous' ScvO monitoring on shock resolution and mortality in children with septic shock.

METHODS

Primary outcome was the achievement of therapeutic goals or shock resolution in the first 6 h. We randomly assigned children < 17 years' age with septic shock to 'intermittent ScvO' or 'continuous ScvO' groups. All children were subjected to subclavian/internal jugular line insertion and managed as per Surviving Sepsis Campaign Guidelines. To guide resuscitation, we used ScvO estimated at other clinical and laboratory parameters were monitored similarly in both groups.

RESULTS

We enrolled 75 and 77 children [median (IQR) age: 6 (1.5-10) years] in the 'intermittent' and 'continuous' groups, respectively. Baseline characteristics were comparable between the groups. When compared to the 'continuous' group, fewer children in the 'intermittent' group achieved shock resolution within first 6 h [19% vs. 36%; relative risk (RR) 0.51; 95% CI 0.29-0.89; risk difference - 18.0%; 95% CI - 32.0 to - 4.0]. The lower bound of confidence interval, however, crossed the pre-specified non-inferiority margin. There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).

CONCLUSIONS

Given that a greater proportion of children attained therapeutic end points in the first 6 h, continuous monitoring of ScvO should preferably be used to titrate therapy in the first few hours in children with septic shock. In the absence of such facility, intermittent monitoring of ScvO can be used to titrate therapy in these children, given the lack of difference in the proportion of patients achieving shock resolution at 24 h or in risk of mortality between the intermittent and continuous groups.

摘要

目的

比较“间歇性”中心静脉血氧饱和度(ScvO)监测与“连续性”ScvO监测对脓毒性休克患儿休克缓解及死亡率的影响。

方法

主要结局是在最初6小时内实现治疗目标或休克缓解。我们将年龄小于17岁的脓毒性休克患儿随机分为“间歇性ScvO”组或“连续性ScvO”组。所有患儿均接受锁骨下/颈内静脉置管,并按照《拯救脓毒症运动指南》进行管理。为指导复苏,我们使用估计的ScvO,两组中其他临床和实验室参数的监测方式相似。

结果

“间歇性”组和“连续性”组分别纳入75例和77例患儿[年龄中位数(四分位间距):6(1.5 - 10)岁]。两组的基线特征具有可比性。与“连续性”组相比,“间歇性”组在最初6小时内实现休克缓解的患儿较少[19%对36%;相对危险度(RR)0.51;95%置信区间0.29 - 0.89;风险差值 - 18.0%;95%置信区间 - 32.0至 - 4.0]。然而,置信区间的下限越过了预先设定的非劣效性界限。两组在24小时内实现休克缓解的患儿比例(63%对69%;RR 0.86;95%置信区间0.68 - 1.08)或死亡率风险(47%对43%;RR 1.06;95%置信区间0.74 - 1.51)并无差异。

结论

鉴于更大比例的患儿在最初6小时内达到治疗终点,对于脓毒性休克患儿,在最初几小时内滴定治疗时,最好使用连续性ScvO监测。在缺乏这种设备的情况下,鉴于间歇性组和连续性组在24小时内实现休克缓解的患者比例或死亡率风险并无差异,可使用间歇性ScvO监测来滴定这些患儿的治疗。

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