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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00339053
Other study ID # C-04.01 TAA
Secondary ID
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
Est. primary completion date
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


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
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