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临床试验/NCT07751692
NCT07751692尚未招募不适用

Prognostic Value of the Geriatric Nutritional Risk Index and Ultrasonographic Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery: A Prospective Observational Study

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Number of Participants With Prolonged Postoperative Hospital Stay

研究概览

简要总结

This prospective observational study will evaluate whether nutritional risk and reduced muscle mass are associated with postoperative outcomes in adults aged 65 years or older undergoing surgery for hip fracture.

Nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), which is calculated from routine preoperative serum albumin, body weight, and ideal body weight. Rectus femoris muscle thickness will be measured before surgery using a brief, noninvasive ultrasound examination of the non-fractured thigh.

Participants will receive routine clinical care, and no treatment or anesthesia method will be assigned by the study. Clinical information will be collected from hospital records, including postoperative length of hospital stay, surgical site infection, and mortality. Survival status will be evaluated at 30 and 90 days after surgery using hospital records and/or telephone follow-up.

详细描述

This is a single-center, prospective observational cohort study involving consecutive patients aged 65 years or older who are scheduled to undergo surgical treatment for hip fracture at Fatih Sultan Mehmet Training and Research Hospital. The study will investigate the prognostic value of the Geriatric Nutritional Risk Index (GNRI) and ultrasonographic rectus femoris muscle thickness (RF-MT) for postoperative clinical outcomes.

After informed consent is obtained, demographic and preoperative clinical data will be recorded, including age, sex, height, weight, body mass index, comorbidities, American Society of Anesthesiologists physical status, fracture type, serum albumin, hemoglobin, C-reactive protein, and creatinine.

The GNRI will be calculated using the following formula:

GNRI = [1.489 × serum albumin (g/L)] + [41.7 × current body weight/ideal body weight].

When the ratio of current body weight to ideal body weight is greater than 1, the ratio will be set to 1. Participants will be classified according to the original GNRI categories: no nutritional risk (GNRI greater than 98), low nutritional risk (GNRI 92 to 98), and moderate or severe nutritional risk (GNRI less than 92).

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

  • •Age 65 years or older
  • •Scheduled to undergo surgical treatment for hip fracture
  • •Provision of informed consent by the participant or, when applicable, a legally authorized representative

排除标准

  • •Pathological fracture or fracture related to malignancy
  • •Advanced neuromuscular disease
  • •Active infection
  • •Planned revision surgery
  • •Lower limb amputation or severe deformity preventing rectus femoris muscle thickness measurement
  • •Inability to obtain informed consent from the participant or a legally authorized representative

研究组 & 干预措施

Geriatric Hip Fracture Cohort

Patients aged 65 years or older undergoing surgical treatment for hip fracture. Preoperative nutritional risk will be assessed using the Geriatric Nutritional Risk Index, and rectus femoris muscle thickness will be measured by ultrasound on the non-fractured side. Participants will receive routine clinical care, and no treatment, anesthesia technique, or surgical intervention will be assigned by the study.

干预措施: Geriatric Nutritional Risk Index Assessment (Other)

结局指标

主要结局

Number of Participants With Prolonged Postoperative Hospital Stay

时间窗: From the date of surgery through discharge from the index hospitalization, assessed up to 30 days after surgery.

Postoperative hospital length of stay will be calculated as the number of days from the date of surgery to the date of discharge. Prolonged postoperative hospital stay will be defined as a length of stay exceeding the 75th percentile of the postoperative length-of-stay distribution in the completed study cohort. The outcome will be reported as the number and percentage of participants meeting this criterion.

次要结局

  • Number of Participants With Surgical Site Infection(From the date of surgery through 90 days after surgery)
  • Number of Participants With 30-Day All-Cause Mortality(within 30 days after surgery)
  • Number of Participants With 90-Day All-Cause Mortality(Within 90 days after surgery)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oznur Demiroluk

Associate Professor of Anesthesiology and Reanimation

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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