n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery
Primary Purpose
Delirium, Dementia, Amnestic, Cognitive Disorders, Postoperative Cognitive Dysfunction
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
n-3 enriched nutrition
Sponsored by
About this trial
This is an interventional prevention trial for Delirium, Dementia, Amnestic, Cognitive Disorders
Eligibility 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
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
n-3 enriched nutrition
isocaloric nutrition without n-3 supplement
Outcomes
Primary Outcome Measures
Incidence of postoperative cognitive dysfunction 7 days postoperatively
Secondary Outcome Measures
Full Information
NCT ID
NCT00757913
First Posted
September 22, 2008
Last Updated
February 23, 2010
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00757913
Brief Title
n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery
Official Title
The Effect of n-3 Enriched Nutrition Therapy on Postoperative Cognitive Dysfunction and Delirium After Elective Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment rate
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Dementia, Amnestic, Cognitive Disorders, Postoperative Cognitive Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
n-3 enriched nutrition
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
isocaloric nutrition without n-3 supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 enriched nutrition
Primary Outcome Measure Information:
Title
Incidence of postoperative cognitive dysfunction 7 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luzius A Steiner, MD, PhD
Organizational Affiliation
Department of Anaesthesia, University Hospital Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery
We'll reach out to this number within 24 hrs