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Clinical Trials/NCT00339053
NCT00339053
Unknown
Phase 4

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

St. Antonius Hospital1 site in 1 country142 target enrollmentSeptember 2004

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Thoracic Aortic Aneurysm
Sponsor
St. Antonius Hospital
Enrollment
142
Locations
1
Primary Endpoint
Lenght of stay ICU
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
January 2008
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Lenght of stay ICU

Incidence infections

days on ventilator support

Secondary Outcomes

  • biochemical markers organ failure
  • biochemical markers infectious parameters

Study Sites (1)

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