Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by St. Antonius Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00339053
First received: June 19, 2006
Last updated: October 20, 2006
Last verified: October 2006

June 19, 2006
October 20, 2006
September 2004
Not Provided
  • days on ventilator support
  • Lenght of stay ICU
  • Incidence infections
Same as current
Complete list of historical versions of study NCT00339053 on ClinicalTrials.gov Archive Site
  • biochemical markers organ failure
  • biochemical markers infectious parameters
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Thoracic Aortic Aneurysm
  • Respiratory Insufficiency
Drug: Immunonutrition ( Impact)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
142
January 2008
Not Provided

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
Both
18 Years and older
No
Contact: Erik Scholten, MD +31306092304 ext 601 scholten_e@wanadoo.nl
Contact: Gert B Brunnekreef, MD +31306092304 ext 377 g.brunnekreef@antonius.net
Netherlands
 
NCT00339053
C-04.01 TAA
Not Provided
Not Provided
St. Antonius Hospital
Not Provided
Study Director: Eric PA van Dongen, phD St. Antonius Hospital
Study Chair: Leon HJ Aarts, PhD University Medical Centre Groningen
Study Director: leo Bras, MD St. Antonius Hospital
Principal Investigator: gert B Brunnekreef, MD St. Antonius Hospital
St. Antonius Hospital
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP