Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
Primary Purpose
Thoracic Aortic Aneurysm, Respiratory Insufficiency
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Immunonutrition ( Impact)
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Aortic Aneurysm focused on measuring thoracic aortic aneurysm, immunonutrition, respiratory failure, lenght of stay ICU
Eligibility 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
Sites / Locations
- st Antonius HospitalRecruiting
Outcomes
Primary Outcome Measures
days on ventilator support
Lenght of stay ICU
Incidence infections
Secondary Outcome Measures
biochemical markers organ failure
biochemical markers infectious parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00339053
Brief Title
Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
Official Title
The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
St. Antonius Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysm, Respiratory Insufficiency
Keywords
thoracic aortic aneurysm, immunonutrition, respiratory failure, lenght of stay ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
142 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Immunonutrition ( Impact)
Primary Outcome Measure Information:
Title
days on ventilator support
Title
Lenght of stay ICU
Title
Incidence infections
Secondary Outcome Measure Information:
Title
biochemical markers organ failure
Title
biochemical markers infectious parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erik Scholten, MD
Phone
+31306092304
Ext
601
Email
scholten_e@wanadoo.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Gert B Brunnekreef, MD
Phone
+31306092304
Ext
377
Email
g.brunnekreef@antonius.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric PA van Dongen, phD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leon HJ Aarts, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
leo Bras, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
gert B Brunnekreef, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
st Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3583 RR
Country
Netherlands
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
11996250
Citation
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.
Results Reference
background
PubMed Identifier
11551575
Citation
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.
Results Reference
background
PubMed Identifier
11509059
Citation
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.
Results Reference
background
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Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
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