Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

Phase 4

• Conditions: Thoracic Aortic Aneurysm; Respiratory Insufficiency

• Registration Number: NCT00339053
• Lead Sponsor: 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

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-20
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-20
• Last Update Posted: 2006-10-23
• Study Completion: 2008-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence infections
Lenght of stay ICU
days on ventilator support

Secondary Outcome Measures

Name	Time	Method
biochemical markers organ failure
biochemical markers infectious parameters

Trial Locations

Locations (1)

st Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands