Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by St. Antonius Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00339053
First received: June 19, 2006
Last updated: October 20, 2006
Last verified: October 2006
  Purpose

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 Intervention Phase
Thoracic Aortic Aneurysm
Respiratory Insufficiency
Drug: Immunonutrition ( Impact)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • days on ventilator support
  • Lenght of stay ICU
  • Incidence infections

Secondary Outcome Measures:
  • biochemical markers organ failure
  • biochemical markers infectious parameters

Estimated Enrollment: 142
Study Start Date: September 2004
Estimated Study Completion Date: January 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339053

Contacts
Contact: Erik Scholten, MD +31306092304 ext 601 scholten_e@wanadoo.nl
Contact: Gert B Brunnekreef, MD +31306092304 ext 377 g.brunnekreef@antonius.net

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

Publications:
ClinicalTrials.gov Identifier: NCT00339053     History of Changes
Other Study ID Numbers: C-04.01 TAA
Study First Received: June 19, 2006
Last Updated: October 20, 2006
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on September 30, 2014