Nutrition Supplementation in Cardiovascular Surgery Patients-A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
This randomized controlled pilot study evaluates the use of oral nutritional supplementation in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is given for 30 days prior to surgery, continuing throughout their surgical hospitalization and ends at hospital discharge. Half of the participants will receive the oral nutritional supplement and the other half will not.
详细描述
Cardiovascular surgery (CVS) is a resource intensive modality in the treatment of coronary artery disease and valvular heart disease. CVS patients who are malnourished experience increased duration of cardiopulmonary bypass, post-operative infections, impaired wound healing, muscle wasting, longer lengths of intensive care unit (ICU) and hospital stay, higher readmission rates, higher treatment costs and marked increases in mortality. Despite the devastating effects of malnutrition in these patients, physicians and health care practitioners are poor in respect to identification, monitoring and treatment of malnutrition.
In two large tertiary hospitals in Ontario, this will be a randomized trial of a novel nutritional pathway to rapidly identify at-risk CVS patients pre-operatively, and then provide oral nutritional supplementation (ONS) during the 30 days prior to surgery, then continue supplementation throughout hospitalization until discharge. Meaningful patient-centered and economic outcomes will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Require cardiovascular surgery
- •Have been assessed in a pre-operative clinic
- •Have an intermediate or high risk Society of Thoracic Surgeons (STS) score
- •Malnutrition Universal Screening Tool (MUST) score of >1.
排除标准
- •Require urgent/emergent cardiovascular surgery
- •Have advanced symptomatic angina or heart failure
- •Are designated palliative care
- •Are currently suffering from refeeding syndrome
- •Have a pre-existing medical condition that prevents oral intake of full fluids
- •Are on a fluid restricted diet
- •Are unable to walk prior to current illness
- •Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
- •Are pregnant or currently breastfeeding.
结局指标
主要结局
Recruitment
时间窗: 1 year
This pilot study will be considered as successfully demonstrating feasibility of recruitment if 60 participants are recruited over 12 months. The overarching objective of this pilot study is to prove feasibility of recruitment and of the protocol in order to continue to a large phase 3 trial.
次要结局
- Functional Performance(30 days post surgery date)
- Nutrition Status(30 days post surgery date)