Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Thoracic Aortic Aneurysm, Respiratory Insufficiency

Intervention / Treatment
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* Drug: Immunonutrition ( Impact)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for elective surgical repair Thoracic or thoraco abdominal aneurysm Exclusion Criteria: endovascular repair pregnancy immunodeficiency use of immunosuppressiva chronic obstructive lung disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immunonutrition ( Impact)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days on ventilator support |  |  | 
| Lenght of stay ICU |  |  | 
| Incidence infections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical markers organ failure |  |  | 
| biochemical markers infectious parameters |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic aortic aneurysm, immunonutrition, respiratory failure, lenght of stay ICU