Clinical trial NCT00339053: Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
Official title: The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thoracic Aortic Aneurysm
Respiratory Insufficiency
Keywords: thoracic aortic aneurysm
immunonutrition
respiratory failure
lenght of stay ICU
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: days on ventilator support
measure: Lenght of stay ICU
measure: Incidence infections
Secondary outcomes:
measure: biochemical markers organ failure
measure: biochemical markers infectious parameters
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: st Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Eric PA van Dongen, phD
role: STUDY_DIRECTOR
affiliation: University Medical Center Groningen
name: Leon HJ Aarts, PhD
role: STUDY_CHAIR
affiliation: St. Antonius Hospital
name: leo Bras, MD
role: STUDY_DIRECTOR
affiliation: St. Antonius Hospital
name: gert B Brunnekreef, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coselli JS, LeMaire SA, Conklin LD, Koksoy C, Schmittling ZC. Morbidity and mortality after extent II thoracoabdominal aortic aneurysm repair. Ann Thorac Surg. 2002 Apr;73(4):1107-15; discussion 1115-6. doi: 10.1016/s0003-4975(02)03370-2.
citation: Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eysman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701. doi: 10.1016/s0140-6736(01)05836-6.
citation: Heyland DK, Novak F, Drover JW, Jain M, Su X, Suchner U. Should immunonutrition become routine in critically ill patients? A systematic review of the evidence. JAMA. 2001 Aug 22-29;286(8):944-53. doi: 10.1001/jama.286.8.944.