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

Brief Summary:

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 or disease Intervention/treatment Phase
Delirium, Dementia, Amnestic, Cognitive Disorders Postoperative Cognitive Dysfunction Dietary Supplement: n-3 enriched nutrition Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00757913     History of Changes
Other Study ID Numbers: EK 92/08
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms