The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta
试验速览
- 阶段
- 4 期
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Lenght of stay ICU
研究概览
简要总结
The purpose of this study is to determine whether immunonutrition and pre operative nutrition can reduce lenght of respirator support, lenght of stay in the ICU and incidence of post operative infections
详细描述
Elective surgical repair of a Thoraco (Abdominal) Aneurysm Aorta (T(A)AA) is associated with high mortality and morbidity. Important complications are renal failure, paraplegia and respiratory failure.
A retrospective study we performed also revealed high post operative infection rates and high incidence of respiratory failure.
Improving immune status may reduce the occurrence of infections due to immune chances. Immunonutrition may enhance the patient's immune system. Many clinical trials of immunonutrition in critically ill and surgical patients have been performed. In meta-analyses it has been shown that immunonutrition results in lower infections rates and shorter 'length of stay' in hospital after major surgery. Immunonutrition has not been studied yet in TAA(A) surgery. Controversy exists in septic patients.
We designed a prospective randomized placebo controlled trial to study the effect of immunonutrition on time on ventilatorsupport, lenght of stay in the intensive care unit and incidence of postoperative infections after TAA(A) surgery. Patients start with oral supplements besides their normal diet 5 days before surgery. After the operation, the nutrition is continued by protocol and administered by nasogastric tube until normal entral feeding is possible. The control group wil receive iso caloric and iso nitrogen nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •patients scheduled for elective surgical repair Thoracic or thoraco abdominal aneurysm
排除标准
- •endovascular repair
- •pregnancy
- •immunodeficiency
- •use of immunosuppressiva
- •chronic obstructive lung disease
结局指标
主要结局
Lenght of stay ICU
Incidence infections
days on ventilator support
次要结局
- biochemical markers organ failure
- biochemical markers infectious parameters
