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

NCT00757913 | Terminated Phase 4

• 1 other identifier: EK 92/08
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium, Dementia, Amnestic, Cognitive Disorders; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive dysfunction 7 days postoperatively

Study Arms (2)

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

Interventions

n-3 enriched nutrition DIETARY_SUPPLEMENT

1; 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient's undergoing elective cardiac procedure with extracorporeal circulation
• Age 65 or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Neurocognitive Disorders; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Luzius A Steiner, MD, PhD

  Department of Anaesthesia, University Hospital Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 24, 2010

Record last verified: 2010-02

Locations

CH (1)