ISRCTN67182335已完成不适用
Effect of an enteral nutrition enriched with eicosapentaenoic acid, gamma-linolenic acid and anti-oxidants on the outcome of mechanically ventilated critically ill septic patients: a phase IV prospective multicentre randomised controlled parallel-group study
Spanish Society of Intensive Care (Sociedad Española de Medicina Intensiva) (Spain)0 个研究点目标入组 272 人开始时间: 2009年12月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Eligible patients are defined as those subjects who satisfy ALL of the following:
- •1. Aged 18 years or older, either sex
- •2. A diagnosis of sepsis during admission to the ICU, without the provision of artificial nutrition in the minimum required amount
- •3. An indication for enteral nutrition
- •4. Patient registration in the Secretariat before the start of treatment
- •5. Informed consent for participation in the study
排除标准
- •Patients who present any of the following will NOT be eligible for inclusion in the study:
- •1. Established pregnancy
- •2. The reception of artificial nutrition in the 15 days prior to inclusion in the study
- •3. Known food allergy to any of the study diet components
- •4. Severe hyperlipidemia and hypertriglyceridemia
- •5. Gastrointestinal diseases precluding enteral nutrition (surgical resections, malabsorption, exacerbated inflammatory disease, persistent ileus, active upper digestive bleeding, etc.)
- •6. The impossibility of positioning the enteral nutrition tube
- •7. Immune depression, defined as:
- •7.1. Neutropenia (less than 1 x 10^9 neutrophils/l), or a prior diagnosis of myelodysplastic syndrome
- •7.2. Congenital immune deficiencies or acquired immune deficiency syndrome (AIDS) (Center for Disease Control and Prevention [CDC] criteria)
- •7.3. Systemic immunosuppressor therapy (including corticosteroids at prednisone equivalent doses of 1 mg/day or more) in the last 3 months
- •7.4. Systemic chemotherapy in the last 3 months
- •7.5. Autologous haematopoietic precursor cell transplantation in the previous year
- •7.6. Allogenic haematopoietic precursor cell transplantation in the last 2 years, or the existence of chronic graft versus host disease
- •8. Advanced chronic diseases:
- •8.1. Stage C chronic liver disease (Child Pugh)
- •8.2. Grade IV heart failure (New York Heart Association [NYHA])
- •8.3. Functional grade IV chronic respiratory failure
- •8.4. End stage degenerative neurological processes
- •8.5. End stage kidney failure
- •8.6. Neoplasms, either relapsing or in progression under treatment
- •9. Short life-expectancy processes:
- •9.1. Shock of any aetiology with multi-organ failure refractory to therapy in the first 48 hours
- •9.2. Fulminant acute hepatitis
- •9.3. Ischaemic haemorrhagic cerebrovascular accidents or head injuries with endocranial hypertension not controlled within 72 hours
- •9.4. Cardiogenic shock not overcome after 72 hours of specific treatment
- •9.5. Incoercible or recurrent serious acute haemorrhage for greater than 72 hours
- •9.6. Haemostatic disorders not controlled after 72 hours of specific treatment
- •9.7. Post-cardiopulmonary resuscitation with serious neurological damage 72 hours after arrest
- •10. Severe acute pancreatitis (except if infection is confirmed)
- •11. Administration of some experimental treatment in the past month, or present inclusion in another clinical study
研究者
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