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Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

NCT ID: NCT00339053

Last Updated: 2006-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Thoracic Aortic Aneurysm Respiratory Insufficiency

Keywords

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thoracic aortic aneurysm immunonutrition respiratory failure lenght of stay ICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Immunonutrition ( Impact)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Eric PA van Dongen, phD

Role: STUDY_DIRECTOR

St. Antonius Hospital

Leon HJ Aarts, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

leo Bras, MD

Role: STUDY_DIRECTOR

St. Antonius Hospital

gert B Brunnekreef, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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st Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Erik Scholten, MD

Role: CONTACT

Phone: +31306092304

Email: [email protected]

Gert B Brunnekreef, MD

Role: CONTACT

Phone: +31306092304

Email: [email protected]

References

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Coselli JS, LeMaire SA, Conklin LD, Koksoy C, Schmittling ZC. Morbidity and mortality after extent II thoracoabdominal aortic aneurysm repair. Ann Thorac Surg. 2002 Apr;73(4):1107-15; discussion 1115-6. doi: 10.1016/s0003-4975(02)03370-2.

Reference Type BACKGROUND
PMID: 11996250 (View on PubMed)

Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eysman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701. doi: 10.1016/s0140-6736(01)05836-6.

Reference Type BACKGROUND
PMID: 11551575 (View on PubMed)

Heyland DK, Novak F, Drover JW, Jain M, Su X, Suchner U. Should immunonutrition become routine in critically ill patients? A systematic review of the evidence. JAMA. 2001 Aug 22-29;286(8):944-53. doi: 10.1001/jama.286.8.944.

Reference Type BACKGROUND
PMID: 11509059 (View on PubMed)

Other Identifiers

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C-04.01 TAA

Identifier Type: -

Identifier Source: org_study_id