Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
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|ClinicalTrials.gov Identifier: NCT00339053|
Recruitment Status : Unknown
Verified October 2006 by St. Antonius Hospital.
Recruitment status was: Recruiting
First Posted : June 20, 2006
Last Update Posted : October 23, 2006
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Aneurysm Respiratory Insufficiency||Drug: Immunonutrition ( Impact)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta|
|Study Start Date :||September 2004|
|Study Completion Date :||January 2008|
- days on ventilator support
- Lenght of stay ICU
- Incidence infections
- biochemical markers organ failure
- biochemical markers infectious parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339053
|Contact: Erik Scholten, MD||+31306092304 ext email@example.com|
|Contact: Gert B Brunnekreef, MD||+31306092304 ext firstname.lastname@example.org|
|st Antonius Hospital||Recruiting|
|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|