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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00757913
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : September 23, 2008
Last Update Posted : February 24, 2010
Information provided by:
University Hospital, Basel, Switzerland

September 22, 2008
September 23, 2008
February 24, 2010
September 2008
September 2009   (Final data collection date for primary outcome measure)
Incidence of postoperative cognitive dysfunction 7 days postoperatively
Same as current
Complete list of historical versions of study NCT00757913 on Archive Site
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n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery
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.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Delirium, Dementia, Amnestic, Cognitive Disorders
  • Postoperative Cognitive Dysfunction
Dietary Supplement: n-3 enriched nutrition
  • Experimental: 1
    n-3 enriched nutrition
    Intervention: Dietary Supplement: n-3 enriched nutrition
  • Placebo Comparator: 2
    isocaloric nutrition without n-3 supplement
    Intervention: Dietary Supplement: n-3 enriched nutrition
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
EK 92/08
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University Hospital, Basel, Switzerland
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Principal Investigator: Luzius A Steiner, MD, PhD Department of Anaesthesia, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP