Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- 30-day incidence infection
研究概览
简要总结
The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.
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, Care Provider, Outcomes Assessor)
盲法说明
Use of enteral formula enriched with omega-3 or standard not revealed for participants.
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
- •Lung cancer diagnosis
- •Elective surgery for lung resection schedule at least four days before surgery
- •Signed informed consent.
排除标准
- •Acute or chronic organ failure as hepatic or renal insufficiency
- •Patients with fish-allergy
- •History of any surgery within 3 months
- •Immunocompromised patients
研究组 & 干预措施
Experimental enteral nutrition
Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula
干预措施: Fish oil enteral supplementation (Dietary Supplement)
Experimental oral nutrition
Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery
干预措施: Fish oil oral supplementation (Dietary Supplement)
Standard enteral nutrition
Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula
干预措施: Enteral nutrition without fish oil (Dietary Supplement)
Standard oral nutrition
Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery
干预措施: Oral nutritional supplement without fish oil (Dietary Supplement)
结局指标
主要结局
30-day incidence infection
时间窗: 30-day incidence infection following lung resection in lung cancer patients.
Incidence of infectious complications after surgery diagnosed using any of these criteria: Infection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray.
次要结局
- Number of participants with therapeutic antibiotics prescription(During the hospital stay until 30-day)
- Changes in Tumor Necrosis Factor Alpha (TNF-α)(At the beginning of nutritional therapy and at day-4 following surgery)
- Changes in prostaglandin E2(At the beginning of nutritional therapy and at day-4 following surgery)
- Hospital lenght of stay(During the hospital stay until 90-day)
- Changes in Interleukin-6(At the beginning of nutritional therapy and at day-4 following surgery)
研究者
Ivan Armando Osuna Padilla
Clinical Nutrition Manager
National Institute of Respiratory Diseases, Mexico