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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

The Effect of n-3 Enriched Nutrition Therapy on Postoperative Cognitive Dysfunction and Delirium After Elective Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00757913
• Other study ID #: EK 92/08
• Status: Terminated
• Phase: Phase 4
• First received: September 22, 2008
• Last updated: February 23, 2010
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2010
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Delirium
• Delirium, Dementia, Amnestic, Cognitive Disorders
• Postoperative Cognitive Dysfunction

Intervention

Dietary Supplement:
• n-3 enriched nutrition

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative cognitive dysfunction 7 days postoperatively			No