Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China
Jia ZY, Yang J, Xia Y, Tong DN, Zaloga GP, Qin HL, OliClinomel N4 Study Group
Nutrition journal · 20 citas
Etiquetas de revisión
Vínculos de autores con la industriaFinanciado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiado por la industria
- Autores
- Al menos un autor declara un vínculo económico con la industria
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2015-11-14 · Nutr J · vol. 14 · número 1 · pág. 119
- Editorial
- BioMed Central
- Citado
- 23 citas · más que el 78% de estudios similares · 1.1× el promedio de su campo
- Referencias
- 43 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Clinical Nutrition and Gastroenterology · Enhanced Recovery After Surgery · Central Venous Catheters and Hemodialysis
- Palabras clave
- prealbumin, insulin-like growth factor I, infection risk, inflammatory markers, surgical patients, non-inferiority
- MeSH
- humans, soybean oil, fat emulsions, intravenous, treatment outcome, parenteral nutrition, prospective studies, middle aged, china, female, male, olive oil
7 autores
- OliClinomel N4 Study Group🇨🇳Shanghai Jiao Tong University; Shanghai Sixth People's Hospital
- Zhen-Yi Jia🇨🇳Shanghai Jiao Tong University; Shanghai Sixth People's Hospital
- Jun Yang🇨🇳Shanghai Jiao Tong University; Shanghai Sixth People's Hospital
- Yang Xia🇨🇳Shanghai Jiao Tong University; Shanghai Sixth People's Hospital
- Danian Tong🇨🇳🇺🇸Shanghai Jiao Tong University; Shanghai Sixth People's Hospital; Baxter (United States)
- Gary Paul Zaloga🇨🇳🇺🇸Shanghai Tenth People's Hospital; Baxter (United States)
- Huanlong Qin🇨🇳 · autor de correspondenciaShanghai Jiao Tong University; Shanghai Tenth People's Hospital; Shanghai Sixth People's Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required.
Methods
Treatments were administered for a minimum of 5 days up to 14 days (to achieve approximately 25 kcal/kg/day, 0.9 g/kg/day amino acids, 0.8 g/kg/day lipid). Impact of treatment on anabolic/catabolic and serum inflammatory, chemistry, and hematological markers, safety, and ease of use were assessed. The primary efficacy variable was serum prealbumin level at Day 5.
Results
OLIVE (n = 219) was not inferior to SOYBEAN (n = 224) based on the prealbumin least square geometric mean [LSGM] ratio [95% CI] 1.12 [1.06, 1.19]; P = 0.002), improved the anabolic/catabolic status of patients enrolled in the study, and was well tolerated compared with SOYBEAN. Improved anabolic status was supported by significantly higher levels of prealbumin at Day 5, albumin at Day 5 and IGF-1 at Day 14 in the OLIVE group, while catabolism was similar between groups. C-reactive protein, intercellular adhesion molecule-1, procalcitonin, and oxidation were similar in each group, but infections were significantly lower with OLIVE (3.6% versus 10.4%; P < 0.01).
Conclusions
OLIVE provided effective nutrition, was well tolerated, was associated with fewer infections, and conferred greater ease-of-use than SOYBEAN.
Trial registration
NTC 01579097.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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