Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Organs dysfunction free days.
研究概览
简要总结
Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up the systemic inflammatory response with its mediators. Sepsis treatment protocols have been established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the studies, immune nutrients were giving parenterally, however, nowadays the preferable route of feeding in critically ill patients is enterally. The present study was done to investigate the effect of enteral Omega-3 fatty acid in septic critically ill patients.
详细描述
A hundred and ten critically ill septic patients were included in the study. Patients were divided into two groups fifty-five patients each. Group A received enteral nutrition supplemented with Omega-3 fatty acid and group B received enteral nutrition without Omega-3. Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, ICU sequential organ failure assessment score (SOFA), organ failure free-days, haemodynamic failure free-days, ICU stay, ICU and hospital outcomes were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All septic patients who could receive enteral nutrition were included in the study
排除标准
- •Patients with end stage liver or renal disease, haemodynamic instability, immunosuppression, gastrointestinal comorbidity, allergic to omega-3, received omega-3 a week prior to ICU admission, patients who expected to live less than 24 hours, and patients who were mechanically ventilated on ICU admission were excluded from the study.
研究组 & 干预措施
Placebo
Patients received enteral nutrition supplemented without 1000 mg omega-3.
干预措施: Placebo (Drug)
Omega 3
Patients received enteral nutrition supplemented with 1000 mg omega-3.
干预措施: Omega 3 (Drug)
结局指标
主要结局
Organs dysfunction free days.
时间窗: 25 days during ICU stay.
The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).
次要结局
未报告次要终点
研究者
Dr Ezzeldin Ibrahim
Assistant Professor in anaesthesia, intensive care, and pain medicine.
Menoufia University