Respiratory Insufficiency Clinical Trial
Official title:
The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco (Abdominal) Aneurysm Aorta
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
Status | Recruiting |
Enrollment | 142 |
Est. completion date | January 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | st Antonius Hospital | Nieuwegein | Utrecht |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Coselli JS, LeMaire SA, Conklin LD, Köksoy 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. — View 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. Review. — View Citation
Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eÿsman 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | days on ventilator support | |||
Primary | Lenght of stay ICU | |||
Primary | Incidence infections | |||
Secondary | biochemical markers organ failure | |||
Secondary | biochemical markers infectious parameters |
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