【ChiCTR2200057463】Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

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基本信息

登记号

ChiCTR2200057463

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2022-03-13

临床申请受理号

靶点

适应症

preoperative protein-calorie malnutrition

试验通俗题目

Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

试验专业题目

Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

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临床试验信息

试验目的

1. 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. 2. 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. 3. To evaluate the effect of nutritional prehabilitation on the length of postoperative stay in malnourished patients undergoing elective cardiac surgery. 4. 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.

试验分类

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

This is a single-center, pragmatic, two-armed, parallel, superiority, blinded randomized controlled trial. Participants will be randomly allocated to either nutritional prehabilitation or usual care (no nutritional prehabilitation) with 1:1 allocation. Block randomization with randomly selected block sizes will be performed.

盲法

Due to the nature of the intervention and requirements of informed consent, trial participants were not blinded to the treatment allocation. Study research personnel who collected the follow-up nutritional status and food frequency intake at hospital admission were blinded from the treatment allocation. Outcome assessors were also blinded to the participant’s group allocation.

试验项目经费来源

department funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-09-01

试验终止时间

2025-08-30

是否属于一致性

入选标准

1. Adults (no age restriction) undergoing elective or non-emergent major to ultra-major cardiac surgery (CABG, valve surgery or combined) 2. 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

1. Redo or emergency cardiac surgery 2. 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. 3. 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] 4. Patients with liver diseases and at risk for hepatic encephalopathy 5. Physical limitations that would preclude regular attendance to outpatient nutritional prehabilitation sessions 6. Seen by a dietician in the last 6 months；

研究者信息

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试验机构

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

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