n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium, Dementia, Amnestic, Cognitive Disorders Postoperative Cognitive Dysfunction |
Dietary Supplement: n-3 enriched nutrition |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effect of n-3 Enriched Nutrition Therapy on Postoperative Cognitive Dysfunction and Delirium After Elective Cardiac Surgery |
- Incidence of postoperative cognitive dysfunction 7 days postoperatively [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
n-3 enriched nutrition
|
Dietary Supplement: n-3 enriched nutrition |
|
Placebo Comparator: 2
isocaloric nutrition without n-3 supplement
|
Dietary Supplement: n-3 enriched nutrition |
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient's undergoing elective cardiac procedure with extracorporeal circulation
- Age 65 or older
Exclusion Criteria:
- No informed written consent
- "Redo" operation
- Deep hypothermic cardiac arrest
- Operation including carotid endarterectomy
- Known allergy to n-3 fatty acids
- History of cerebrovascular disease
- Preoperative Mini mental score < 23
- Long term neuroleptic medication
Contacts and Locations| Switzerland | |
| University Hospital Basel | |
| Basel, Switzerland, 4031 | |
| Principal Investigator: | Luzius A Steiner, MD, PhD | Department of Anaesthesia, University Hospital Basel, Switzerland |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00757913 History of Changes |
| Other Study ID Numbers: | EK 92/08 |
| Study First Received: | September 22, 2008 |
| Last Updated: | February 23, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium Dementia Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Confusion |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013