Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong, People's Republic of China.
Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, People's Republic of China.
BMJ Open. 2023 Jul 20;13(7):e069528. doi: 10.1136/bmjopen-2022-069528.
Protein malnutrition is associated with higher risks of postoperative complications, mortality, prolonged postoperative stays in hospital, slower physical and mental recovery after surgery and lower subsequent health-related quality of life. To reduce the risk of postoperative morbidity and mortality, nutritional prehabilitation programmes have been developed recently to build up patient's nutritional reserve to withstand the stress of surgery. The intervention involves nutritional screening and counselling, and increasing dietary protein intake in protein-malnourished patients in the several weeks before surgery. However, there are few well-conducted preoperative studies to examine the effect of increasing dietary protein intake on the quality of recovery of malnourished patients after elective cardiac surgery.
This randomised controlled trial of malnourished patients undergoing major elective cardiac surgery will compare the quality of postoperative recovery in patients with or without nutritional prehabilitation. One hundred and thirty-two patients will be randomised to receive nutritional prehabilitation (target-adjusted whey protein powder supplementation and an individualised 1 hour session/week counselling by a dietician 1 month before operation date) or standard care (no nutritional prehabilitation). Primary outcomes will be the quality of recovery after surgery (15-item Quality of Recovery) on the third postoperative day. Secondary outcomes will include days (alive and) at home within 30 days, changes in the WHO Disability Assessment Schedule 2.0, changes in health-related quality of life (EQ-5D) and Cardiac Postoperative Morbidity Survey. An outcomes assessor will be blinded to the treatment allocation. Appropriate univariate analyses, generalised estimating equations and multiple regressions will be performed for intention-to-treat and per-protocol analyses.
The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No.: 2021.703 T). The findings will be presented at scientific meetings, peer-reviewed journals and to study participants.
ChiCTR2200057463.
蛋白质营养不良与术后并发症风险增加、死亡率升高、术后住院时间延长、术后身体和精神恢复较慢以及随后健康相关生活质量降低有关。为了降低术后发病率和死亡率，最近开发了营养预康复计划，以增强患者的营养储备，以承受手术的压力。该干预措施包括营养筛查和咨询，并在手术前几周增加蛋白质营养不良患者的饮食蛋白质摄入量。然而，很少有精心设计的术前研究来检查增加饮食蛋白质摄入量对择期心脏手术后营养不良患者康复质量的影响。
这项针对接受重大择期心脏手术的营养不良患者的随机对照试验将比较营养预康复组和常规护理组患者术后康复质量的差异。将 132 名患者随机分为营养预康复组（目标调整乳清蛋白粉补充和营养师在手术日期前 1 个月每周进行 1 小时个体咨询）或常规护理组（无营养预康复）。主要结局是术后第 3 天的康复质量（15 项康复质量）。次要结局包括术后 30 天内在家（存活）的天数、世界卫生组织残疾评估量表 2.0 的变化、健康相关生活质量（EQ-5D）和心脏术后发病率调查的变化。结局评估者将对治疗分配保持盲态。将进行适当的单变量分析、广义估计方程和多元回归分析，以进行意向治疗和方案分析。
香港中文大学-新界东联网临床研究伦理委员会批准了该研究方案（CREC 参考号：2021.703T）。研究结果将在科学会议、同行评议期刊和研究参与者中报告。
ChiCTR2200057463。
