Mesejo Alfonso, Montejo-González Juan Carlos, Vaquerizo-Alonso Clara, Lobo-Tamer Gabriela, Zabarte-Martinez Mercedes, Herrero-Meseguer Jose Ignacio, Acosta-Escribano Jose, Blesa-Malpica Antonio, Martinez-Lozano Fátima
Intensive Care Unit, Hospital Clínico Universitario, Avda Blasco Ibáñez 17, 46010, Valencia, Spain.
Intensive Care Unit, Hospital Universitario 12 de Octubre, Avda de Cordoba s/n, 28041, Madrid, Spain.
Crit Care. 2015 Nov 9;19:390. doi: 10.1186/s13054-015-1108-1.
Although standard enteral nutrition is universally accepted, the use of disease-specific formulas for hyperglycemic patients is still controversial. This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-acquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV).
This was a prospective, open-label, randomized (web-based, blinded) study conducted at nine Spanish ICUs. The patient groups established according to the high-protein formula received were: group A, new-generation diabetes-specific formula; group B, standard control formula; group C, control diabetes-specific formula. Inclusion criteria were: expected enteral nutrition ≥5 days, MV, baseline glucose >126 mg/dL on admission or >200 mg/dL in the first 48 h. Exclusion criteria were: APACHE II ≤10, insulin-dependent diabetes, renal or hepatic failure, treatment with corticosteroids, immunosuppressants or lipid-lowering drugs and body mass index ≥40 kg/m(2). The targeted glucose level was 110-150 mg/dL. Glycemic variability was calculated as the standard deviation, glycemic lability index and coefficient of variation. Acquired infections were recorded using published consensus criteria for critically ill patients. Data analysis was on an intention-to-treat basis.
Over a 2-year period, 157 patients were consecutively enrolled (A 52, B 53 and C 52). Compared with the standard control formula, the new formula gave rise to lower insulin requirement (19.1 ± 13.1 vs. 23.7 ± 40.1 IU/day, p <0.05), plasma glucose (138.6 ± 39.1 vs. 146.1 ± 49.9 mg/dL, p <0.01) and capillary blood glucose (146.1 ± 45.8 vs. 155.3 ± 63.6 mg/dL, p <0.001). Compared with the control diabetes-specific formula, only capillary glucose levels were significantly reduced (146.1 ± 45.8 vs. 150.1 ± 41.9, p <0.01). Both specific formulas reduced capillary glucose on ICU day 1 (p <0.01), glucose variability in the first week (p <0.05), and incidences of ventilator-associated tracheobronchitis (p <0.01) or pneumonia (p <0.05) compared with the standard formula. No effects of the nutrition formula were produced on hospital stay or mortality.
In these high-risk ICU patients, both diabetes-specific formulas lowered insulin requirements, improved glycemic control and reduced the risk of acquired infections relative to the standard formula. Compared with the control-specific formula, the new-generation formula also improved capillary glycemia.
Clinicaltrials.gov NCT1233726 .
尽管标准肠内营养已被广泛接受，但针对高血糖患者使用疾病特异性配方仍存在争议。本研究旨在探讨一种高蛋白糖尿病特异性配方是否能降低重症机械通气（MV）的高血糖患者的胰岛素需求，改善血糖控制并减少ICU获得性感染。
这是一项在西班牙9个ICU进行的前瞻性、开放标签、随机（基于网络，双盲）研究。根据所接受的高蛋白配方建立的患者组为：A组，新一代糖尿病特异性配方；B组，标准对照配方；C组，对照糖尿病特异性配方。纳入标准为：预期肠内营养≥5天、MV、入院时基线血糖>126mg/dL或前48小时内>200mg/dL。排除标准为：急性生理与慢性健康状况评分系统（APACHE II）≤10、胰岛素依赖型糖尿病、肾或肝功能衰竭、使用皮质类固醇、免疫抑制剂或降脂药物治疗以及体重指数≥40kg/m²。目标血糖水平为110 - 150mg/dL。血糖变异性计算为标准差、血糖不稳定指数和变异系数。使用已发表的重症患者共识标准记录获得性感染。数据分析采用意向性分析。
在2年期间，连续纳入157例患者（A组52例、B组53例和C组52例）。与标准对照配方相比，新配方导致胰岛素需求降低（19.1±13.1 vs. 23.7±40.1IU/天，p<0.05）、血浆葡萄糖降低（138.6±39.1 vs. 146.1±49.9mg/dL，p<0.01）和毛细血管血糖降低（146.1±45.8 vs. 155.3±63.6mg/dL，p<0.001）。与对照糖尿病特异性配方相比，仅毛细血管血糖水平显著降低（146.1±45.8 vs. 150.1±41.9，p<0.01）。与标准配方相比，两种特异性配方均降低了ICU第1天的毛细血管血糖（p<0.01）、第一周的血糖变异性（p<0.05）以及呼吸机相关性气管支气管炎（p<0.01）或肺炎（p<0.05）的发生率。营养配方对住院时间或死亡率无影响。
在这些高危ICU患者中，两种糖尿病特异性配方相对于标准配方均降低了胰岛素需求，改善了血糖控制并降低了获得性感染的风险。与对照特异性配方相比，新一代配方还改善了毛细血管血糖水平。
Clinicaltrials.gov NCT1233726 。
