Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00339053
• Other study ID #: C-04.01 TAA
• Status: Recruiting
• Phase: Phase 4
• First received: June 19, 2006
• Last updated: October 20, 2006
• Start date: September 2004
• Est. completion date: January 2008

Study information

• Verified date: October 2006
• Source: St. Antonius Hospital
• Contact: Erik Scholten, MD
• Phone: +31306092304
• Email: scholten_e[@]wanadoo.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Thoracic Aortic Aneurysm

Intervention

Drug:
• Immunonutrition ( Impact)

Locations

Country	Name	City	State
Netherlands	st Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Coselli JS, LeMaire SA, Conklin LD, Köksoy 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. — View 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. Review. — View Citation

Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eÿsman 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days on ventilator support
Primary	Lenght of stay ICU
Primary	Incidence infections
Secondary	biochemical markers organ failure
Secondary	biochemical markers infectious parameters