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n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery

This study has been terminated.
(Insufficient recruitment rate)
Information provided by:
University Hospital, Basel, Switzerland Identifier:
First received: September 22, 2008
Last updated: February 23, 2010
Last verified: February 2010

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: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Incidence of postoperative cognitive dysfunction 7 days postoperatively

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


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00757913

University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Luzius A Steiner, MD, PhD Department of Anaesthesia, University Hospital Basel, Switzerland
  More Information Identifier: NCT00757913     History of Changes
Other Study ID Numbers: EK 92/08
Study First Received: September 22, 2008
Last Updated: February 23, 2010

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms processed this record on September 21, 2017