Department of General Intensive Care, Institute for Nutrition Research, Rabin Medical Center, 49100, Petah Tikva, Israel.
Intensive Care Med. 2015 Mar;41(3):460-9. doi: 10.1007/s00134-015-3646-z. Epub 2015 Feb 12.
Severe injury triggers a complex systemic immune response which may result in significant respiratory compromise, including the development of acute respiratory distress syndrome (ARDS). No randomized clinical trial has assessed the role of nutritional interventions to limit respiratory complications.
This was a single-center, prospective, randomized, comparative, double-blind, controlled study of patients with severe trauma requiring mechanical ventilation. Patients were randomly assigned to receive either a control formula (n = 58) or a formula enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA) and antioxidants (n = 62) at time of admission to the intensive care unit (ICU). Primary outcome measures included the level of oxygenation (PaO2/FiO2 ratio, PF ratio) on days 4 and 8, incidence of acute lung injury (ALI) and/or ARDS and length of ventilation. The development of infectious complications and fatty acid red blood cell membrane composition were also assessed.
In this intention-to-treat population, no significant differences between the control and study groups were found for the PF ratio at day 4 (213.7 ± 85.6 vs. 227.2 ± 67.7, respectively; P = 0.24) and day 8 (187.8 ± 65.2 vs. 188.9 ± 56.0, respectively; P = 0.82), the incidence of ARDS/ALI (24.1 vs. 29.0 %, respectively; P = 0.68), length of ventilation time (13.6 ± 10.7 vs. 17.0 ± 15.1 days, respectively; P = 0.15), duration of ICU stay (16.4 ± 11.3 vs. 19.5 ± 15.3 days, respectively; P = 0.21) and 28-day mortality (8.6 vs. 12.9 %, respectively P = 0.56). While the study group showed a significant increase in EPA and GLA concentrations at day 4 (P = 0.05) and day 8 (P < 0.001), the Omega-3 Index (O-3I) failed to reach those suggested as being optimal to obtain clinical efficacy. The significantly higher incidence of bacteremia noted in the study group (P = 0.03) was associated with a higher number of patients with multiple trauma and a higher red blood cell transfusion requirement (P = 0.008).
This study failed to show a significant benefit for the preemptive use of the study formula in patients with severe trauma. Additional studies need to be performed in which the amount of supplementation is targeted to a potentially measurable endpoint, e.g. the O-3I.
严重损伤会引发复杂的全身免疫反应，可能导致严重的呼吸功能障碍，包括急性呼吸窘迫综合征（ARDS）的发生。尚无随机临床试验评估营养干预以限制呼吸并发症的作用。
这是一项单中心、前瞻性、随机、对照、双盲、临床试验，纳入了需要机械通气的严重创伤患者。患者随机分为对照组（n=58）和实验组（n=62），分别于入住重症监护病房（ICU）时接受常规配方或富含二十碳五烯酸（EPA）、γ-亚麻酸（GLA）和抗氧化剂的配方。主要观察指标包括第 4 天和第 8 天的氧合水平（PaO2/FiO2 比值，PF 比值）、急性肺损伤（ALI）和/或 ARDS 的发生率和通气时间。还评估了感染并发症和红细胞膜脂肪酸组成的发生情况。
在这项意向治疗人群中，对照组和实验组第 4 天的 PF 比值（分别为 213.7±85.6 和 227.2±67.7；P=0.24）和第 8 天的 PF 比值（分别为 187.8±65.2 和 188.9±56.0；P=0.82）、ARDS/ALI 发生率（分别为 24.1%和 29.0%；P=0.68）、通气时间（分别为 13.6±10.7 和 17.0±15.1 天；P=0.15）、ICU 入住时间（分别为 16.4±11.3 和 19.5±15.3 天；P=0.21）和 28 天死亡率（分别为 8.6%和 12.9%；P=0.56）无显著差异。实验组第 4 天（P=0.05）和第 8 天（P<0.001）EPA 和 GLA 浓度显著升高，但 Omega-3 指数（O-3I）未能达到获得临床疗效的最佳水平。实验组更高的菌血症发生率（P=0.03）与更多多发创伤患者和更高的红细胞输注需求相关（P=0.008）。
本研究未能显示严重创伤患者预防性使用研究配方有显著获益。需要开展进一步的研究，将补充剂的剂量针对潜在可衡量的终点，例如 O-3I。
