Venet Fabienne, Plassais Jonathan, Textoris Julien, Cazalis Marie-Angélique, Pachot Alexandre, Bertin-Maghit Marc, Magnin Christophe, Rimmelé Thomas, Monneret Guillaume, Tissot Sylvie
Hospices Civils de Lyon, Cellular Immunology Laboratory, Hôpital E Herriot, Pavillon E - 5 place d'Arsonval, Lyon, Cedex 03 69437, France.
Hospices Civils de Lyon, Université Claude Bernard Lyon I, Lyon EAM 4174, Lyon, 69008, France.
Crit Care. 2015 Jan 26;19(1):21. doi: 10.1186/s13054-015-0740-0.
The aim of this study was to assess the effect of low-dose corticosteroid therapy in reducing shock duration after severe burn.
A placebo-controlled, double-blind, randomized clinical trial (RCT) was performed on two parallel groups in the burn intensive care unit (ICU). Patients were randomized to receive either low-dose corticosteroid therapy or placebo for seven days. A corticotropin test was performed at the time of randomization, before the administration of the treatment dose. Thirty-two severely burned patients with refractory shock (>0.5 μg/kg/min of norepinephrine) were prospectively included in the study.
We included 12 patients in the hydrocortisone-treated group and 15 patients in the placebo group in the final analysis. Among these patients, 21 were nonresponders to the corticotropin test. Median norepinephrine treatment duration (primary objective) was significantly lower in the corticosteroid-treated versus the placebo group (57 hours versus 120 hours, P = 0.035). The number of patients without norepinephrine 72 hours after inclusion was significantly lower in the treated group (P = 0.003, log-rank test analysis). The total quantities of norepinephrine administered to patients were lower in the hydrocortisone-treated versus the placebo group (1,205 μg/kg (1,079 to 2,167) versus 1,971 μg/kg (1,535 to 3,893), P = 0.067). There was no difference in terms of ICU or hospital length of stay, sepsis incidence, cicatrization or mortality.
In this placebo-controlled, randomized, double-blind clinical trial, we show for the first time that the administration of low-dose hydrocortisone in burn patients with severe shock reduces vasopressor administration.
Clinicaltrial.gov NCT00149123 . Registered 6 September 2005.
本研究旨在评估低剂量皮质类固醇疗法对缩短严重烧伤后休克持续时间的效果。
在烧伤重症监护病房（ICU）对两个平行组进行了一项安慰剂对照、双盲、随机临床试验（RCT）。患者被随机分为接受低剂量皮质类固醇疗法或安慰剂治疗7天。在随机分组时、给予治疗剂量之前进行促肾上腺皮质激素试验。前瞻性纳入了32例难治性休克（去甲肾上腺素>0.5μg/kg/min）的严重烧伤患者。
最终分析中，氢化可的松治疗组纳入12例患者，安慰剂组纳入15例患者。在这些患者中，21例对促肾上腺皮质激素试验无反应。与安慰剂组相比，皮质类固醇治疗组的去甲肾上腺素治疗持续时间中位数（主要指标）显著更低（57小时对120小时，P = 0.035）。纳入后72小时无去甲肾上腺素使用的患者数量在治疗组显著更低（P = 0.003，对数秩检验分析）。与安慰剂组相比，氢化可的松治疗组患者接受的去甲肾上腺素总量更低（1205μg/kg（1079至2167）对1971μg/kg（1535至3893），P = 0.067）。在ICU住院时间、住院时间、脓毒症发生率、瘢痕形成或死亡率方面无差异。
在这项安慰剂对照、随机、双盲临床试验中，我们首次表明，对严重休克的烧伤患者给予低剂量氢化可的松可减少血管升压药的使用。
Clinicaltrial.gov NCT00149123。2005年9月6日注册。
