Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
Recruitment status was: Recruiting
Thoracic Aortic Aneurysm
Drug: Immunonutrition ( Impact)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta|
- days on ventilator support
- Lenght of stay ICU
- Incidence infections
- biochemical markers organ failure
- biochemical markers infectious parameters
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||January 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00339053
|st Antonius Hospital|
|Nieuwegein, Utrecht, Netherlands, 3583 RR|
|Study Director:||Eric PA van Dongen, phD||St. Antonius Hospital|
|Study Chair:||Leon HJ Aarts, PhD||University Medical Center Groningen|
|Study Director:||leo Bras, MD||St. Antonius Hospital|
|Principal Investigator:||gert B Brunnekreef, MD||St. Antonius Hospital|