Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
Recruitment status was Recruiting
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| First Received Date ICMJE | June 19, 2006 | ||||||||||||||||
| Last Updated Date | October 20, 2006 | ||||||||||||||||
| Start Date ICMJE | September 2004 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00339053 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair | ||||||||||||||||
| Official Title ICMJE | The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta | ||||||||||||||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 4 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Immunonutrition ( Impact) | ||||||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Enrollment ICMJE | 142 | ||||||||||||||||
| Completion Date | January 2008 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00339053 | ||||||||||||||||
| Other Study ID Numbers ICMJE | C-04.01 TAA | ||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||
| Study Sponsor ICMJE | St. Antonius Hospital | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | St. Antonius Hospital | ||||||||||||||||
| Verification Date | October 2006 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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