Postoperative Cognitive Dysfunction Clinical Trial
Official title:
The Effect of n-3 Enriched Nutrition Therapy on Postoperative Cognitive Dysfunction and Delirium After Elective Cardiac Surgery
Background: Delirium and long-term cognitive dysfunction (CD) are important complications of
major surgery and intensive care treatment. Delirium is associated with increased mortality
and CD has an important impact on mortality, independency, social interactions, and quality
of life. Delirium is an important risk factor for the development of long-term CD.
Particularly, patients aged 65 or older undergoing cardiac surgery are at a high risk of
developing these problems. There are data suggesting that inflammation plays a key role in
the development of delirium and possibly CD. It has been shown that n-3 fatty acids modulate
the immune response of patients and have beneficial effects in abdominal surgery.
Working hypothesis: 1. Administration of n-3 enriched nutrition therapy including will
modulate the inflammatory response and improve cognitive function after cardiac surgery.
Specific Aims: This project will test the impact of perioperative enteral n-3 fatty acids
ProSure, Abbott Nutrition) in elderly patients undergoing elective cardiac surgery. Primary
endpoint is CD one week postoperatively.
Methods: The investigators will investigate 400 patients aged 65 or older undergoing
elective cardiac surgery. Half of these patients will receive supplementary of n-3 fatty
acids to modulate the inflammatory response; the other half will receive an isocaloric
nutritional supplement without n-3 fatty acids (Ensure Plus, Abbott Nutrition). Otherwise
the treatment of the patients will not be influenced by this study. Cognitive function will
be assessed preoperatively, 7 days and three months postoperatively. C-reactive protein,
IL-6, IL-8, IL-10, S-100B, and neuron specific enolase will be monitored as markers of
systemic inflammation and delirium.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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