Multi-centre, Open-label, Phase II Clinical Trial for Determination of the Optimal Dose of Fish Oil in Patients With Severe Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Change in SOFA score
研究概览
简要总结
The primary objective of this trial is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters
详细描述
Objectives: The overall objective is to determine the effect of IV fish oil on 28-day mortality of critically ill patients with severe sepsis. However, prior to such a large trial, we need to determine the optimal dose of IV fish oils in this population. Therefore, the primary objective of this proposal (FOILED) is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters.
Study Design: This is a multi-centre, open-label, phase I dose ranging clinical trial with prospective controls.
Setting: 2 tertiary care ICUs in Germany (Universitätsklinikum Carl Gustav Carus, Dresden and University Hospital Giessen and Marburg, Giessen).
Patients: Mechanically ventilated adult patients (>18 years old) admitted to ICU with clinical evidence of sepsis, sepsis associated organ dysfunction, and high expression of inflammatory cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ICU patients
- •Requiring invasive or non-invasive ventilation
- •Clinical evidence of sepsis
- •Presence of one or more organ failures
排除标准
- •>24 hours from admission to ICU to time of consent
- •Low level of inflammatory cytokine (IL-6(qualitative assay <100 pg/ml)
- •lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
- •Immunocompromised (post-organ transplantation, HIV, neutropenic [<1000 PMN], steroids >20 mgs/day for 6 months).
- •Chronic non-invasive ventilation (except if they become mechanically ventilated)
- •Platelet count of < 30 GPt/L
- •Pregnant patients. Urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice.
- •Previous enrollment in this study
- •Enrollment in other ICU intervention study
- •Allergy to fish or fish oil (shellfish allergy not an exclusion criterion)
- •Has already received enteral or IV omega-3 fatty acids during this hospitalization and current ICU admission.
结局指标
主要结局
Change in SOFA score
时间窗: Day 1-10
As the primary goal of this study is to establish the safety of high doses of IV fish oils, our primary outcomes will be change in SOFA score (organ function) and biochemical parameters of safety (i.e. blood lipid levels, coagulation parameters, bleeding episodes, standard biochemistry).
次要结局
- Clinical outcomes(Day 1-28)
- Markers of systemic inflammation(Day 1-10)
研究者
Axel R. Heller
MD
University Hospital Carl Gustav Carus