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氢化可的松与精氨酸加压素用于复苏后休克:HYVAPRESS试验

Hydrocortisone and arginine vasopressin in post-resuscitation shock: the HYVAPRESS trial.

作者信息

Geri Guillaume, Lascarrou Jean-Baptiste, Levy Bruno, Asfar Pierre, Muller Grégoire, Legriel Stéphane, Ricôme Sylvie, Cour Martin, Klouche Kada, Sauneuf Bertrand, Quenot Jean Pierre, Bougouin Wulfran, Cariou Alain

机构信息

Service de Réanimation Polyvalente, Groupe Hospitalier Privé Ambroise Paré - Hartmann, Neuill-Sur-Seine F-92200, France.

Réseau AfterRosc, France.

出版信息

Resusc Plus. 2025 May 19;24:100982. doi: 10.1016/j.resplu.2025.100982. eCollection 2025 Jul.

Abstract

BACKGROUND

Acute circulatory failure after successfull resuscitation of cardiac arrest remains challenging and multifactorial. As the main driver of early mortality after restoration of spontaneous circulation, its therapeutic management essentially relies on fluids administration and vasopressive support using noradrenaline. Data also support the potential impact of a hormonal defect in this setting. Steroids substitution as well as argini-vasopressin treatment should be evaluated in these patients.

METHODS

The HYVAPRESS trial is a 2x2 factorial randomized placebo-controlled multicentric trial evaluating the effect of both hydrocortisone and arginin-vasopressin in successfully resuscitated (inhospital and out-of-hospital) cardiac arrest patients suffering an acute circulatory failure in the first 24 h after restoration of spontaneous circulation. The main outcome will be the favourable neurological outcome assessed by the Glasgow Outcome Scale (GOS). 380 patients will be included, i.e. 95 patients in each arm, allowing the detection of a 15% difference in mortality using a power of 80% and an alpha-risk of 5%.

DISCUSSION

Assessing therapeutics in the hemodynamic failure in post -cardiac arrest patients is challenging as the mortality is very high. Besides the vasopressive support, few investigation have been led so far to improve the management of these patients. While hydrocortisone and arginin-vasopressive have been evaluated in septic shock patients, data are lacking in this very specific subgroup of patients suffering from a very high mortality. Enrollement is ongoing.

TRIAL REGISTRATION

Clinical Trials NCT04591990, registered on 2020, October 19th.

摘要

背景

心脏骤停成功复苏后的急性循环衰竭仍然具有挑战性且是多因素导致的。作为自主循环恢复后早期死亡的主要驱动因素,其治疗管理主要依赖于液体输注和使用去甲肾上腺素的血管升压支持。数据也支持激素缺陷在这种情况下的潜在影响。应在这些患者中评估类固醇替代以及精氨酸加压素治疗。

方法

HYVAPRESS试验是一项2×2析因随机安慰剂对照多中心试验,评估氢化可的松和精氨酸加压素对在自主循环恢复后的最初24小时内发生急性循环衰竭的成功复苏(院内和院外)心脏骤停患者的影响。主要结局将是通过格拉斯哥预后量表(GOS)评估的良好神经学结局。将纳入380例患者,即每组95例患者,使用80%的检验效能和5%的α风险,能够检测出死亡率15%的差异。

讨论

评估心脏骤停后患者血流动力学衰竭的治疗方法具有挑战性,因为死亡率非常高。除了血管升压支持外,到目前为止,几乎没有进行过改善这些患者管理的研究。虽然氢化可的松和精氨酸加压素已在感染性休克患者中进行了评估,但在这个死亡率非常高的特定患者亚组中缺乏相关数据。入组正在进行中。

试验注册

临床试验NCT04591990,于2020年10月19日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da48/12152864/3403de30d7b7/gr1.jpg

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