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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 [ Designated as safety issue: No ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
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

ClinicalTrials.gov Identifier: NCT00757913     History of Changes
Other Study ID Numbers: EK 92/08
Study First Received: September 22, 2008
Last Updated: February 23, 2010
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 18, 2014