Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Incidence of delirium or non-delirium complications after surgery
研究概览
简要总结
Hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. Malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. This study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.
详细描述
Elderly patients with hip fracture have a high rate of malnutrition. In a cohort study of hip fracture patients aged 70 years or older, 18.8% have malnutrition and 44.6% are at risk of malnutrition. Increasing evidence suggest that preoperative nutritional status has a significant impact on clinical outcomes of elderly patients following surgery. For example, preoperative malnutrition or risk of malnutrition is associated with increased delirium, increased non-delirium complications, prolonged hospital stay, high mortality, and even worse long-term survival after surgery. We speculate that perioperative nutritional intervention may reduce postoperative delirium and improve early and long-term clinical outcomes in elderly hip-fracture patients. The purpose of this study is to observe the effect of perioperative nutritional intervention on early postoperative delirium and complications as well as long-term survival in the patients with malnutrition or at risk of malnutrition who are scheduled for hip-fracture surgery.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 years old;
- •Hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours;
- •Classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (MNA-SF);
- •Provide written informed consents.
排除标准
- •Pathological fracture;
- •History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery;
- •Unable to communicate due to coma, severe dementia, or language barrier;
- •Unable to eat due to any disease in the gastrointestinal system;
- •Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (New York Heart Association classification ≥IV), or American Socisty of Anesthesiologists classification ≥IV;
- •Preexisting organ injury before surgery (delirium, acute kidney injury, myocardial injury, etc.);
- •Other conditions that are considered unsuitable for study participation.
研究组 & 干预措施
Nutritional intervention group
Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g [12 spoon, 500 kcal]/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g [12 spoon, 440 kcal]/day, twice a day).
干预措施: Nutritional intervention group (Dietary Supplement)
Control group
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Incidence of delirium or non-delirium complications after surgery
时间窗: Up to 30 days after surgery
Delirium is assessed twice daily with Confusion Assessment Method (CAM) or CAM for the Intensive Care Unit (CAM-ICU) during the first 5 days after surgery. Non-delirium complications indicate newly occurred conditions (other than delirium) that are harmful to patients' recovery and required therapeutic intervention within 30 days after surgery.
次要结局
- Incidence of organ injury within 5 days after surgery(Up to 5 days after surgery)
- Incidence of non-delirium complications after surgery(Up to 30 days after surgery)
- Cognitive function at 30 days after surgery(At 30 days after surgery.)
- Length of intensive care unit stay after surgery(Up to 30 days after surgery)
- Length of hospital stay after surgery(Up to 30 days after surgery.)
- Quality of life at 30 days after surgery(At 30 days after surgery.)
- Intensive care unit admission after surgery(Within 24 hours after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital