Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Intensive Care Med. 2017 Nov;43(11):1585-1593. doi: 10.1007/s00134-017-4786-0. Epub 2017 Apr 18.
PURPOSE: The aim of the INSTINCT trial was to assess the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo on self-reported physical function in intensive care unit (ICU) patients with necrotising soft tissue infection (NSTI). METHODS: We randomised 100 patients with NSTI 1:1 to masked infusion of 25 g of IVIG (Privigen, CSL Behring) or an equal volume of 0.9% saline once daily for the first 3 days of ICU admission. The primary outcome was the physical component summary (PCS) score of the 36-item short form health survey (SF-36) 6 months after randomisation; patients who had died were given the lowest possible score (zero). RESULTS: Of the 100 patients randomised, 87 were included in the intention-to-treat analysis of the PCS score, 42 patients (84%) in the IVIG group and 45 patients (90%) in the placebo group. The two intervention groups had similar baseline characteristics with the exception of IVIG use before randomisation (1 dose was allowed) and rates of acute kidney injury. Median PCS scores were 36 (interquartile range 0-43) in the group assigned to IVIG and 31 (0-47) in the group assigned to placebo (mean adjusted difference 1 (95% confidence interval -7 to 10), p = 0.81). The result was supported by analyses adjusted for baseline prognostics, those in the per protocol populations, in the subgroups (site of NSTI) and those done post hoc adjusted for IVIG use before randomisation. CONCLUSIONS: In ICU patients with NSTI, we observed no apparent effects of adjuvant IVIG on self-reported physical functioning at 6 months. TRIAL REGISTRATION: NCT02111161.
目的:INSTINCT 试验的目的是评估静脉注射多特异性免疫球蛋白 G(IVIG)与安慰剂相比对重症监护病房(ICU)患有坏死性软组织感染(NSTI)的患者自我报告的身体功能的影响。
方法:我们将 100 名 NSTI 患者以 1:1 的比例随机分为 2 组,分别接受 25g IVIG(Privigen,CSL Behring)或相同体积的 0.9%生理盐水,每天 1 次,共 3 天。主要结局是随机分组后 6 个月的 36 项简短健康调查(SF-36)的物理成分综合评分(PCS);已死亡的患者给予最低可能评分(零)。
结果:在随机分组的 100 名患者中,87 名患者被纳入 PCS 评分的意向治疗分析,IVIG 组 42 名(84%),安慰剂组 45 名(90%)。两组干预组除随机分组前的 IVIG 使用(允许使用 1 剂)和急性肾损伤发生率外,具有相似的基线特征。分配给 IVIG 的组的中位 PCS 评分为 36(四分位距 0-43),分配给安慰剂的组为 31(0-47)(平均调整差异 1(95%置信区间-7 至 10),p=0.81)。该结果得到了调整基线预后、符合方案人群、亚组(NSTI 部位)和事后调整随机分组前 IVIG 使用的分析的支持。
结论:在 ICU 患有 NSTI 的患者中,我们未观察到辅助 IVIG 对 6 个月时自我报告的身体功能有明显影响。
试验注册:NCT02111161。
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