法国南特大学Karim Asehnoune团队比较了持续输注高渗盐水与标准护理对颅脑损伤患者6个月时神经功能预后的影响。2021年5月25日，该研究发表在《美国医学会杂志》上。

液体疗法是脑外伤患者护理的一个重要组成部分，但它是否能改善临床结局尚不清楚。

为了探讨持续输注高渗盐水能否改善颅脑损伤患者6个月时的神经功能状况，研究组在法国9个重症监护病房进行了一项多中心、随机、临床试验，2017年10月至2019年8月，共招募了370名中重度颅脑损伤的患者，随访于2020年2月完成。将这些中重度颅脑损伤成人患者随机分组，其中185例接受20%高渗盐水持续输注加标准护理，185例仅接受标准护理。如果患者仍有颅内高压风险，则给予20%高渗盐水48小时或更长时间。

主要结局为6个月时的扩展格拉斯哥转归量表（GOS-E）评分（范围为1-8分，评分越低表明功能转归越差），由盲法评估者集中获得，并根据预先指定的预后因素进行有序逻辑回归分析。在多个时间点测量了12个次要结局，包括颅内高压和6个月死亡率。

370例患者的中位年龄为44岁，77名（20.2%）为女性，共有359名（97%）完成了试验。6个月时GOS-E评分的校正OR为1.02。在12个次要结局中，有10个在两组间没有显著差异。干预组中有62例（33.7%）患者发生颅内高压，对照组中有66例（36.3%）。干预组中有29例（15.9%）患者在6个月内死亡，对照组中有37例（20.8%），组间差异不显著。

研究结果表明，对于中重度创伤性脑损伤患者，持续输注20%高渗盐水治疗与标准治疗相比，6个月时神经功能状况并没有明显改善。

附：英文原文

Title: Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial

Author: Antoine Roquilly, Jean Denis Moyer, Olivier Huet, Sigismond Lasocki, Benjamin Cohen, Claire Dahyot-Fizelier, Kevin Chalard, Philippe Seguin, Caroline Jeantrelle, Véronique Vermeersch, Thomas Gaillard, Raphael Cinotti, Dominique Demeure dit Latte, Pierre Joachim Mahe, Mickael Vourc’h, Florian Pierre Martin, Alice Chopin, Celine Lerebourg, Laurent Flet, Anne Chiffoleau, Fanny Feuillet, Karim Asehnoune, Atlanrea Study Group and the Société Franaise d’Anesthésie Réanimation (SFAR) Research Network, Hélène Beloeil, Yoann Launey, Audrey Tawa, Rémy Bellier, Thierry Bénard, Soizic Gergaud, Maxime Léger, Pierre-Francois Perrigault, Camille Hego, Mathilde Holleville, Hourmant Yannick, Bouras Marwan, Remérand Francis, Bourdiol Alexandre, Carole Ichai, Nino Stocchetti, Nicolas Molinari

Issue&Volume: 2021/05/25

Abstract:

Importance  Fluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.

Objective  To determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.

Design, Setting, and Participants  Multicenter randomized clinical trial conducted in 9 intensive care units in France, including 370 patients with moderate to severe traumatic brain injury who were recruited from October 2017 to August 2019. Follow-up was completed in February 2020.

Interventions  Adult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n=185) or standard care alone (controls; n=185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.

Main Outcomes and Measures  The primary outcome was Extended Glasgow Outcome Scale (GOS-E) score (range, 1-8, with lower scores indicating worse functional outcome) at 6 months, obtained centrally by blinded assessors and analyzed with ordinal logistic regression adjusted for prespecified prognostic factors (with a common odds ratio [OR] >1.0 favoring intervention). There were 12 secondary outcomes measured at multiple time points, including development of intracranial hypertension and 6-month mortality.

Results  Among 370 patients who were randomized (median age, 44 [interquartile range, 27-59] years; 77 [20.2%] women), 359 (97%) completed the trial. The adjusted common OR for the GOS-E score at 6 months was 1.02 (95% CI, 0.71-1.47; P=.92). Of the 12 secondary outcomes, 10 were not significantly different. Intracranial hypertension developed in 62 (33.7%) patients in the intervention group and 66 (36.3%) patients in the control group (absolute difference, 2.6% [95% CI, 12.3% to 7.2%]; OR, 0.80 [95% CI, 0.51-1.26]). There was no significant difference in 6-month mortality (29 [15.9%] in the intervention group vs 37 [20.8%] in the control group; absolute difference, 4.9% [95% CI, 12.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).

Conclusions and Relevance  Among patients with moderate to severe traumatic brain injury, treatment with continuous infusion of 20% hypertonic saline compared with standard care did not result in a significantly better neurological status at 6 months. However, confidence intervals for the findings were wide, and the study may have had limited power to detect a clinically important difference.

DOI: 10.1001/jama.2021.5561

Source: https://jamanetwork.com/journals/jama/article-abstract/2780326