跳至主要内容
临床试验/NCT06531460
NCT06531460招募中不适用

Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection

National Institute of Respiratory Diseases, Mexico2 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2024年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
310
试验地点
2
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

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

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

  • 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)
  • Number of participants with therapeutic antibiotics prescription(During the hospital stay until 30-day)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ivan Armando Osuna Padilla

Clinical Nutrition Manager

National Institute of Respiratory Diseases, Mexico

研究点 (2)

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