Financiado en parte por Abbott Laboratories, Pfizer
Enteral nutrition with eicosapentaenoic acid, γ-linolenic acid and antioxidants in the early treatment of sepsis: results from a multicenter, prospective, randomized, double-blinded, controlled study: the INTERSEPT study
Pontes-Arruda A, Martins LF, Martins LF, de Lima SM, Isola AM, Toledo D, Rezende E, Maia M, Magnan GB, Investigating Nutritional Therapy with EPA, GLA and Antioxidants Role in Sepsis Treatment (INTERSEPT) Study Group
Critical care (London, England) · 90 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
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Abbott Laboratories
- Empresa
- Pfizer
- Universidad u hospital
- Universidade Federal da Paraíba
- Autores
- Al menos un autor declara un vínculo económico con la industria
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2011-06-09 · Crit Care · vol. 15 · número 3 · pág. R144
- Editorial
- BioMed Central
- Citado
- 148 citas · más que el 99% de estudios similares · 11.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 52 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Clinical Nutrition and Gastroenterology · Sepsis Diagnosis and Treatment · Nosocomial Infections in ICU
- Palabras clave
- enteral nutrition, eicosapentaenoic acid, gamma-linolenic acid, omega-3 fatty acids, sepsis, septic shock, antioxidants, omega-6 fatty acids, organ failure, cardiovascular failure, respiratory failure, length of hospital stay, mortality, early sepsis treatment, anti-inflammatory activity, mechanical ventilation, ICU length of stay
- MeSH
- humans, sepsis, eicosapentaenoic acid, gamma-linolenic acid, antioxidants, treatment outcome, enteral nutrition, prospective studies, double-blind method, time factors, aged, aged, 80 and over, middle aged, female, male
9 autores
- Alessandro Pontes‐Arruda🇧🇷 · autor de correspondenciaHospital Fernandes Távora
- Laércia Ferreira Martins🇧🇷Hospital Fernandes Távora
- Samya Maria de Lima🇧🇷Hospital Fernandes Távora
- Alexandre Marini Ísola🇧🇷Hospital do Servidor Público Estadual
- Diogo Oliveira Toledo🇧🇷Hospital do Servidor Público Estadual
- Ederlon Alves de Carvalho Rezende🇧🇷Hospital do Servidor Público Estadual
- Marcelo Maia🇧🇷Hospital Santa Luzia
- Gisele Brocco Magnan🇧🇷Hospital Santa Luzia
- the Investigating Nutritional Therapy with EPA, GLA and Antioxidants Role in Sepsis Treatment (INTERSEPT) Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
Introduction
Enteral nutrition (EN) with eicosapentaenoic acid (EPA)/γ-linolenic acid (GLA) is recommended for mechanically ventilated patients with severe lung injury. EPA/GLA has anti-inflammatory benefits, as evidenced by its association with reduction in pulmonary inflammation, improvement in oxygenation and improved clinical outcomes in patients with severe forms of acute lung injury. This study was a prospective, multicenter, randomized, double-blinded, controlled trial designed to investigate whether EPA/GLA could have an effective role in the treatment of patients with early sepsis (systemic inflammatory response syndrome with confirmed or presumed infection and without any organ dysfunction) by reducing the progression of the disease to severe sepsis (sepsis associated with at least one organ failure) or septic shock (sepsis associated with hypotension despite adequate fluid resuscitation). Secondary outcomes included the development of individual organ failure, increased ICU and hospital length of stay, need for mechanical ventilation and 28-day all-cause mortality.
Methods
Randomization was concealed, and patients were allocated to receive, for seven days, either an EPA/GLA diet or an isocaloric, isonitrogenous control diet not enhanced with lipids. Patients were continuously tube-fed at a minimum of 75% of basal energy expenditure × 1.3. To evaluate the progression to severe sepsis and/or septic shock, daily screening for individual organ failure was performed. All clinical outcomes were recorded during a 28-day follow-up period.
Results
A total of 115 patients in the early stages of sepsis requiring EN were included, among whom 106 were considered evaluable. Intention-to-treat (ITT) analysis demonstrated that patients fed the EPA/GLA diet developed less severe sepsis and/or septic shock than patients fed the control diet (26.3% versus 50%, respectively; P = 0.0259), with similar results observed for the evaluable patients (26.4% versus 50.9% respectively; P = 0.0217). The ITT analysis demonstrated that patients in the study group developed cardiovascular failure (36.2% versus 21%, respectively; P = 0.0381) and respiratory failure (39.6% versus 24.6%, respectively; P = 0.0362) less often than the control group. Similarly, when considering only the evaluable patients, fewer patients developed cardiovascular failure (20.7% versus 37.7%, respectively; P = 0.03) and respiratory failure (26.4% versus 39.6%, respectively; P = 0.04). The percentage of patients fed the EPA/GLA diet requiring invasive mechanical ventilation was reduced compared with controls (ITT patients: 18.9% versus 33.9%, respectively; P = 0.394; evaluable patients: 17.5% versus 34.5%, respectively; P = 0.295). Patients nourished with the EPA/GLA diet remained in the ICU fewer days than the control population (ITT patients: 21.1 ICU-free days versus 14.7 ICU-free days, respectively; P < 0.0001; evaluable patients: 20.8 ICU-free days versus 14.3 ICU-free days, respectively; P < 0.0001) and fewer days at the hospital (ITT patients: 19.5 hospital-free days versus 10.3 hospital-free days, respectively; P < 0.0001; evaluable patients: 19.1 hospital-free days versus 10.2 hospital-free days, respectively; P < 0.001) (all numbers expressed as means). No significant differences in 28-day all-cause mortality were observed (ITT patients: 26.2% EPA/GLA diet versus 27.6% control diet, respectively; P = 0.72; evaluable: 26.4 EPA/GLA diet versus 30.18 control diet, respectively; P = 0.79).
Conclusions
These data suggest that EPA/GLA may play a beneficial role in the treatment of enterally fed patients in the early stages of sepsis without associated organ dysfunction by contributing to slowing the progression of sepsis-related organ dysfunction, especially with regard to cardiovascular and respiratory dysfunction.
Trial registration
ClinicalTrials.gov: NCT00981877.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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