Respiratory Insufficiency Clinical Trial
Official title:
The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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