ChiCTR2200057463招募中4 期
Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial
department funding1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年9月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- quality of recovery
研究概览
简要总结
- To determine the potential for dietitian guided change in preoperative dietary protein intake levels in malnourished patients scheduled for elective cardiac surgery undergoing nutritional prehabilitation.
- To evaluate the effect of high-quality dietary protein intake on the quality of recovery after elective cardiac surgery in malnourished patients undergoing nutritional prehabilitation.
- To evaluate the effect of nutritional prehabilitation on the length of postoperative stay in malnourished patients undergoing elective cardiac surgery.
- To determine the synergistic effect of preoperative dietary protein intake and physical activity on quality of recovery after elective cardiac surgery in malnourished patients undergoing nutritional prehabilitation.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Adults (no age restriction) undergoing elective or non-emergent major to ultra-major cardiac surgery (CABG, valve surgery or combined)
- •MUST>0 or FFMI<17 for men or FFMI<15 for women or SMI<7 for men or SMI<5.7 for women
- •Patients on the elective cardiac surgery waiting list are routinely assessed the Perioperative Medicine Clinic several weeks before the scheduled operation date. After written informed consent, patients will complete the MUST questionnaire and undertake a body composition test using a bioelectrical impedance analysis device (InBody 270, InBodyUSA, Cerritos, CA) to measure FFMI and SMI for study eligibility determination.
排除标准
- •Redo or emergency cardiac surgery
- •Major comorbidities precluding surgery, are mentally incompetent, any current disorder impairing accurate and objective completion of the malnutrition assessment and questionnaires, or are unable to understand Chinese or English.
- •CKD not on dialysis requiring low protein diet, advanced stage CKD or end-stage renal disease on dialysis with protein requirements of 1.0 to 1.2 g/kg body weight/day will be excluded [38]
- •Patients with liver diseases and at risk for hepatic encephalopathy
- •Physical limitations that would preclude regular attendance to outpatient nutritional prehabilitation sessions
- •Seen by a dietician in the last 6 months
研究组 & 干预措施
Intervention group
nutrition counseling and protein supplements
Control group
current practice
结局指标
主要结局
quality of recovery
Days (alive and) at home within 30 (DAH30) days after cardiac surgery
次要结局
- Disability-free survival at 30 after surgery
- Health-related quality of life
- Cardiac Postoperative Morbidity Survey (C-POM)
研究者
研究点 (1)
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