Medical University Department, University of Basel, Kantonsspital Aarau, Aarau, Switzerland.
University of Basel, Basel, Switzerland.
JAMA Netw Open. 2020 Mar 2;3(3):e200663. doi: 10.1001/jamanetworkopen.2020.0663.
Inflammation is a key driver of malnutrition during illness and is often accompanied by metabolic effects, including insulin resistance and reduction of appetite. However, it still remains unclear if inflammation influences the response to nutritional support among patients with disease-related malnutrition.
To examine whether patients' baseline inflammatory status is associated with the effect of nutritional support on 30-day mortality.
DESIGN, SETTING, AND PARTICIPANTS: This is a secondary analysis of the Effect of Early Nutritional Support on Frailty, Functional Outcomes, and Recovery of Malnourished Medical Inpatients Trial (EFFORT), a randomized clinical trial conducted in 8 Swiss hospitals from April 2014 to February 2018. A total of 1950 participants who had C-reactive protein measurements at the time of admission were included in this secondary analysis. Data analysis was conducted between June and July 2019.
Hospitalized patients at risk for malnutrition were randomly assigned to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group).
The primary end point was 30-day mortality. Based on C-reactive protein levels at admission, patients were stratified into groups with low, moderate, or high inflammation (<10 mg/L, 10-100 mg/L, and >100 mg/L, respectively).
A total of 1950 patients (median [interquartile range] age, 75 [65-83] years; 1025 [52.6%] men) were included; 533 (27.3%) had low levels of inflammation, 894 (45.9%) had moderate levels of inflammation, and 523 (26.8%) had high levels of inflammation. Compared with the control group, patients receiving nutritional support showed a significant reduction in 30-day mortality, regardless of C-reactive protein level (adjusted odds ratio, 0.61; 95% CI, 0.43-0.86; P = .005). In the subgroup of patients with high inflammation, there was no beneficial effect of nutritional support (adjusted odds ratio, 1.32; 95% CI, 0.70-2.50; P = .39), providing evidence that inflammation has a significant modifying association (P for interaction = .005).
Based on this secondary analysis of a multicenter randomized trial, a patient's admission inflammatory status was associated with their response to nutritional support. If validated in future clinical trials, nutritional support may need to be individualized based on a patient's initial presentation and markers of inflammation. These results may also help to explain some of the heterogeneity in treatment effects of nutrition seen in previous critical care trials.
ClinicalTrials.gov Identifier: NCT02517476.
炎症是疾病期间营养不良的关键驱动因素，常伴有代谢效应，包括胰岛素抵抗和食欲减退。然而，目前仍不清楚炎症是否会影响疾病相关营养不良患者对营养支持的反应。
研究患者基线炎症状态是否与营养支持对 30 天死亡率的影响有关。
设计、地点和参与者：这是对“早期营养支持对虚弱、功能结局和营养不良的医疗住院患者恢复的影响”（EFFORT）的二次分析，这是一项在瑞士 8 家医院进行的随机临床试验，从 2014 年 4 月至 2018 年 2 月进行。共纳入 1950 名入院时进行 C-反应蛋白测量的参与者进行二次分析。数据分析于 2019 年 6 月至 7 月进行。
有营养不良风险的住院患者被随机分配接受以达到蛋白质和能量目标为目标的个体化营养支持（干预组）或标准医院食物（对照组）。
主要终点是 30 天死亡率。根据入院时 C-反应蛋白水平，将患者分为低、中、高炎症组（<10mg/L、10-100mg/L 和>100mg/L 分别为）。
共纳入 1950 名患者（中位数[四分位间距]年龄，75[65-83]岁；1025[52.6%]为男性）；533 名（27.3%）患者炎症水平较低，894 名（45.9%）患者炎症水平中等，523 名（26.8%）患者炎症水平较高。与对照组相比，无论 C-反应蛋白水平如何，接受营养支持的患者 30 天死亡率均显著降低（调整后的优势比，0.61；95%CI，0.43-0.86；P=0.005）。在炎症水平较高的患者亚组中，营养支持无获益效应（调整后的优势比，1.32；95%CI，0.70-2.50；P=0.39），表明炎症具有显著的修饰关联（P 交互=0.005）。
基于这项多中心随机试验的二次分析，患者入院时的炎症状态与他们对营养支持的反应有关。如果在未来的临床试验中得到验证，营养支持可能需要根据患者的初始表现和炎症标志物进行个体化。这些结果也可能有助于解释之前在重症监护试验中观察到的营养治疗效果的一些异质性。
ClinicalTrials.gov 标识符：NCT02517476。
