Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00339053
Recruitment Status : Unknown
Verified October 2006 by St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2006
Last Update Posted : October 23, 2006
Information provided by:
St. Antonius Hospital

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

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysm Respiratory Insufficiency Drug: Immunonutrition ( Impact) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta
Study Start Date : September 2004
Estimated Study Completion Date : January 2008

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U.S. FDA Resources

Primary Outcome Measures :
  1. days on ventilator support
  2. Lenght of stay ICU
  3. Incidence infections

Secondary Outcome Measures :
  1. biochemical markers organ failure
  2. biochemical markers infectious parameters

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00339053

Contact: Erik Scholten, MD +31306092304 ext 601
Contact: Gert B Brunnekreef, MD +31306092304 ext 377

st Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3583 RR
Sponsors and Collaborators
St. Antonius Hospital
Study Director: Eric PA van Dongen, phD St. Antonius Hospital
Study Chair: Leon HJ Aarts, PhD University Medical Center Groningen
Study Director: leo Bras, MD St. Antonius Hospital
Principal Investigator: gert B Brunnekreef, MD St. Antonius Hospital

Publications: Identifier: NCT00339053     History of Changes
Other Study ID Numbers: C-04.01 TAA
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006

Keywords provided by St. Antonius Hospital:
thoracic aortic aneurysm
respiratory failure
lenght of stay ICU

Additional relevant MeSH terms:
Aortic Aneurysm
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases