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UnknownNCT00339053

Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
142 (planned)
Sponsor
St. Antonius Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGImmunonutrition ( Impact)

Timeline

Start date
2004-09-01
Completion
2008-01-01
First posted
2006-06-20
Last updated
2006-10-23

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00339053. Inclusion in this directory is not an endorsement.