Evaluation of the Effects of Preoperative Oral Nutritional Support on Hemodynamic Stability, Morbidity, Mortality, and Anthropometric Measurements in Patients With Femur Fractures and High Frailty Index: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Change in Pleth Variability Index (ΔPVI)
研究概览
简要总结
The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. The main questions it aims to answer are:
- Does preoperative nutrition support improve hemodynamic stability during and after surgery?
- Does it reduce postoperative complications, mortality, and length of hospital stay?
Researchers will compare patients who receive preoperative oral nutrition support with those who follow routine nutrition.
Participants will:
- Receive routine medical care with or without nutrition support
- Have their hemodynamic values, complications, and outcomes recorded during hospitalization
- Be followed at 30 and 90 days after surgery for complications and mortality.
详细描述
Femur fractures in elderly patients with a high frailty index are associated with increased perioperative morbidity and mortality. Malnutrition is common in this population and may worsen hemodynamic instability, delay recovery, and increase postoperative complications. Although nutritional support has been studied in geriatric patients, data specific to frail patients with femur fractures are limited.
This prospective observational study will be conducted at the Düzce University Faculty of Medicine, Department of Anesthesiology and Reanimation, between January 2026 and December 2027. Patients aged 65 years or older with femur fractures and a Clinical Frailty Scale score ≥5 who are scheduled for surgery and expected to require postoperative intensive care will be included. Nutritional status will be assessed using NRS-2002 and Food Quality Score Index questionnaires.
Participants will be observed in two groups according to routine clinical practice: patients receiving preoperative oral nutritional support recommended by the nutrition clinic, and patients continuing their usual diet without additional support. No intervention will be assigned by the investigators.
Hemodynamic parameters will be recorded intraoperatively and during postoperative intensive care and ward follow-up. Anthropometric measurements (arm and waist circumference), laboratory values, morbidity, mortality, ICU length of stay, and total hospital stay will be documented. Patients will also be evaluated at postoperative 30 and 90 days for complications and survival.
The study aims to determine whether preoperative nutritional support is associated with improved hemodynamic stability and reduced morbidity and mortality in frail elderly patients with femur fractures. The results may guide perioperative nutritional strategies in high-risk geriatric surgical populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older hospitalized with a diagnosis of femur fracture
- •High frailty index (Clinical Frailty Scale ≥ 5)
- •Patients expected to require postoperative intensive care
排除标准
- •Patients requiring preoperative intensive care
- •Patients unable to tolerate enteral nutrition
- •Patients with advanced liver or kidney failure
- •Patients unable to cooperate
- •Patients with neuromuscular disease
- •Patients with severe malnutrition according to NRS-2002 guidelines
- •Patients who refuse to participate
研究组 & 干预措施
Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward.
Elderly patients with femur fractures and high frailty who receive preoperative oral nutritional supplements in the orthopedic ward according to routine nutrition clinic recommendations. Patients are followed perioperatively and postoperatively for hemodynamic stability, complications, and mortality.
干预措施: Oral Nutritional Supplement (ONS) (Dietary Supplement)
Group 2: Patients followed with routine dietary intake without additional nutritional support.
Elderly patients with femur fractures and high frailty who continue their usual diet without additional nutritional support before surgery. Patients are followed with the same perioperative and postoperative outcome measurements for comparison.
结局指标
主要结局
Change in Pleth Variability Index (ΔPVI)
时间窗: perioperatively/periprocedurally
PVI values recorded with finger-probe noninvasive hemodynamic monitoring; ΔPVI will be calculated across predefined perioperative time points as an indicator of hemodynamic stability.
次要结局
- ICU Length of Stay(From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.)
- Postoperative Morbidity Rate(During hospital stay, and at postoperative 30 and 90 days)
- All-Cause Mortality(During hospital stay, and at postoperative 30 and 90 days)
- Total Hospital Length of Stay(From hospital admission to hospital discharge during the index hospitalization, assessed up to 90 days postoperatively.)
- Anthropometric Measurements (Arm and Waist Circumference Change)(Baseline (Day 1 of hospitalization) and at hospital discharge during the index hospitalization, assessed up to 90 days.)
- Serum Albumin Level Change(Baseline (Day 1 of hospitalization) and preoperative period (within 24 hours before surgery), assessed up to 90 days.)
- Intraoperative Hemodynamic Events(perioperatively/periprocedurally)
研究者
Özlem Ersoy Karka
Assistant Professor
Duzce University