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

This study has been terminated.
(Insufficient recruitment rate)
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00757913
First received: September 22, 2008
Last updated: February 23, 2010
Last verified: February 2010

September 22, 2008
February 23, 2010
September 2008
September 2009   (final data collection date for primary outcome measure)
Incidence of postoperative cognitive dysfunction 7 days postoperatively [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00757913 on ClinicalTrials.gov 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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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00757913
EK 92/08
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University Hospital, Basel, Switzerland
Not Provided
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