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临床试验/NCT00339053
NCT00339053Unknown4 期

The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta

St. Antonius Hospital2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2004年9月最近更新:
适应症
相关药物

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

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

研究者

申办方类型
Other

研究点 (2)

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