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n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery
This study is currently recruiting participants.
Verified by University Hospital, Basel, Switzerland, November 2008
First Received: September 22, 2008   Last Updated: November 28, 2008   History of Changes
Sponsored by: University Hospital, Basel, Switzerland
Information provided by: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00757913
  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 IV

MedlinePlus related topics: Dementia Dietary Supplements Heart Surgery Nutritional Support Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title: The Effect of n-3 Enriched Nutrition Therapy on Postoperative Cognitive Dysfunction and Delirium After Elective Cardiac Surgery

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

Primary Outcome Measures:
  • Incidence of postoperative cognitive dysfunction 7 days postoperatively [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2008
Arms Assigned Interventions
1: Experimental
n-3 enriched nutrition
Dietary Supplement: n-3 enriched nutrition
2: Placebo Comparator
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757913

Contacts
Contact: Luzius A Steiner, MD PhD ++41 (0)61 265 25 25 lsteiner@uhbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Luzius A Steiner, MD PhD     ++41 (0)61 265 25 25     lsteiner@uhbs.ch    
Contact: Steiner            
Principal Investigator: Luzius A Steiner, MD PhD            
Sub-Investigator: Dagmar Birkner-Binder            
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Luzius A Steiner, MD, PhD Department of Anaesthesia, University Hospital Basel, Switzerland
  More Information

No publications provided

Study ID Numbers: EK 92/08
Study First Received: September 22, 2008
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00757913     History of Changes
Health Authority: Switzerland: Ethikkommission

Study placed in the following topic categories:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Confusion
Dementia
Neurobehavioral Manifestations
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Confusion
Neurobehavioral Manifestations
Cognition Disorders
Delirium

ClinicalTrials.gov processed this record on May 07, 2009