跳至主要内容
临床试验/NCT00757913
NCT00757913终止4 期

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

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
入组人数
400
试验地点
2
主要终点
Incidence of postoperative cognitive dysfunction 7 days postoperatively

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Incidence of postoperative cognitive dysfunction 7 days postoperatively

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other

研究点 (2)

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