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Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00339053
Enrollment
142
Registered
2006-06-20
Start date
2004-09-30
Completion date
2008-01-31
Last updated
2006-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency, Thoracic Aortic Aneurysm

Keywords

thoracic aortic aneurysm, immunonutrition, respiratory failure, lenght of stay ICU

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.

Interventions

DRUGImmunonutrition ( Impact)

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
days on ventilator support
Lenght of stay ICU
Incidence infections

Secondary

MeasureTime frame
biochemical markers organ failure
biochemical markers infectious parameters

Countries

Netherlands

Contacts

Primary ContactErik Scholten, MD
scholten_e@wanadoo.nl+31306092304
Backup ContactGert B Brunnekreef, MD
g.brunnekreef@antonius.net+31306092304

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026