Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood
研究概览
简要总结
Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.
The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
- •Age between 60 and 80 years
- •BMI between 20 kg/m2 and below 30 kg/m2
- •Written informed consent
排除标准
- •Participation in or having participated in another clinical trial within the previous 3 months
- •Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve
- •Pre-operative Hemoglobin<5.0 mmol/L
- •Metastatic disease
- •Very poor peripheral venous access
- •Current history of inflammatory or infectious disease
- •The use of anti-inflammatory drugs
- •The use of thyroid medication
- •The use of fish oil products or fish consumption more than 2 times a week
- •Contra-indication for the use of Omegaven-Fresenius, including:
- •General contra-indications for parenteral nutrition
- •Allergy to fish or egg protein.
研究组 & 干预措施
Placebo
2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.
干预措施: Placebo (Drug)
Omegaven
2 infusions of 2ml/kg, one the night before surgery and one the day after surgery
干预措施: Omegaven (Drug)
结局指标
主要结局
Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood
时间窗: baseline, day of surgery, postoperative day 1,2 and 4
Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine IL-6, measured in ng/ml.
次要结局
- Change in erythrocyte function(baseline, day of surgery, postoperative day 1, 2 and 4)
- Change in in vivo systemic inflammatory response parameters(baseline, day of surgery, postoperative day 1, 2 and 4)
- Change in ex vivo production of TNF-α and IL-10 in LPS stimulated whole blood(baseline, day of surgery, postoperative day 1, 2 and 4)
研究者
Alexander P.J. Houdijk
Dr.
Medical Center Alkmaar