RT Journal Article T1 Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study. A1 Mesejo, Alfonso A1 Montejo-González, Juan Carlos A1 Vaquerizo-Alonso, Clara A1 Lobo-Tamer, Gabriela A1 Zabarte-Martinez, Mercedes A1 Herrero-Meseguer, Jose Ignacio A1 Acosta-Escribano, Jose A1 Blesa-Malpica, Antonio A1 Martinez-Lozano, Fátima K1 Glucemia K1 Diabetes Mellitus K1 Nutrición enteral K1 Índice glucémico K1 Humanos K1 Hiperglucemia K1 Insulina K1 Estado nutricional K1 Estudios prospectivos K1 Enfermedad crítica K1 Unidades de cuidados intensivos AB INTRODUCTIONAlthough 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).METHODSThis 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.RESULTSOver 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.CONCLUSIONSIn 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.TRIAL REGISTRATIONClinicaltrials.gov NCT1233726 . PB BioMed Central SN 1364-8535 YR 2015 FD 2015-11-09 LK http://hdl.handle.net/10668/2311 UL http://hdl.handle.net/10668/2311 LA en NO Mesejo A, Montejo-González JC, Vaquerizo-Alonso C, Lobo-Tamer G, Zabarte-Martinez M, Herrero-Meseguer JI, et al. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study. Crit Care. 2015; 19:390 NO Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; DS RISalud RD Apr 7, 2025