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Nutrition and Trauma - The Influence of Malnutrition in Geriatric Trauma Patients (NuTra)

Nutrition and Trauma (NuTra) - The Influence of Malnutrition in Geriatric Trauma Patients

Due to demographic changes, the geriatric patient population is growing, leading to a higher incidence of osteoporotic fractures associated with multimorbidity and frailty. Up to 60% of elderly patients are at risk of malnutrition, which is associated with a high rate of post-operative complications, prolonged hospitalisation, poorer return to independence and increased mortality.

The NuTra study investigates the prevalence of malnutrition, evaluates screening tools and analyses the impact of protein-rich diets on postoperative outcomes in geriatric trauma. The aim is to develop evidence-based approaches to the prevention and treatment of malnutrition in order to improve the medical outcome and quality of life of geriatric trauma patients and reduce healthcare costs.

研究概览

详细说明

Rising life expectancy in Germany-with an average of 78.3 years for men and 83.2 years for women in 2022-is leading to a growing geriatric patient population and posing new challenges for the healthcare system. In clinical practice, individuals aged 65 years and older are generally considered geriatric patients. The incidence of osteoporotic fractures increases with age. These fractures, often resulting from low-energy falls, are frequently the consequence of multimorbidity and increased frailty.

Proximal femur fractures are among the most common fractures requiring inpatient treatment in Germany and are associated with a one-year mortality rate of up to 28%. In addition to osteoporosis, affected patients often present with multiple chronic conditions, contributing to reduced quality of life and substantially increased healthcare costs.

The risk of malnutrition, as assessed by the Nutritional Risk Screening (NRS), is high in geriatric patients in orthopaedics and trauma surgery and increases with age (approximately 31% in patients aged 65-80 years and up to 60% in those over 80 years). Malnutrition is associated with higher rates of postoperative complications (37.2% vs. 21.1%), prolonged hospital stay (18.2 ± 11.7 vs. 13.7 ± 11.1 days), delayed mobilisation, and impaired recovery of autonomy. It is also linked to increased six-month mortality following proximal femur fractures.

Geriatric trauma patients are typically in a catabolic state, particularly in the preoperative phase, which is further exacerbated by the combined effects of trauma, surgery, and perioperative fasting. This often results in metabolic imbalances that may persist for several weeks and increase the risk of complications such as delirium. Despite improvements in care structures, osteoporotic fractures remain a major life event, with only a minority of patients regaining their pre-fracture functional status and independence.

The management of geriatric trauma patients therefore requires an interdisciplinary and comprehensive approach aimed at restoring function, maintaining independence, and preserving quality of life. A key component of this approach-yet still insufficiently addressed-is the early identification and targeted treatment of malnutrition.

研究类型

介入性

注册 (实际的)

218

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tübingen、德国、72076
        • Department of Trauma and Reconstructive Surgery, University of Tuebingen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

描述

Inclusion criteria:

  • Patients aged ≥70 years
  • Acute fractures of the proximal humerus, vertebral body, pelvis, acetabulum, proximal femur, or periprosthetic fractures of the lower extremity
  • Admission for acute fracture management
  • Ability to provide written informed consent

Exclusion criteria:

  • Age <70 years
  • Dementia or relevant cognitive impairment precluding informed consent
  • Progressive malignancy
  • Palliative treatment goals
  • Refusal or inability to provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A Intervention
Malnourished patients in Group A received a structured protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day
The intervention group A received a structured protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day, in accordance with current recommendations for older adults with acute illness. This regimen combined three protein-rich main meals per day with oral nutritional supplements providing 20 g protein per serving.
无干预:Group B Control
Patients in the malnourished control group (B) received standard hospital whole food diet without targeted protein enrichment or routine provision of oral nutritional supplements
无干预:Group C Control
Patients in the well-nourished control group (C) received standard hospital whole food diet without targeted protein enrichment or routine provision of oral nutritional supplements

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants with medical complications during index hospitalization
大体时间:Day 1 (Baseline, Hospital admission) up to 3 weeks.
Number of participants with one or more medical complications during the index hospitalization, including acute kidney injury, urinary tract infection, pneumonia, or deep vein thrombosis.
Day 1 (Baseline, Hospital admission) up to 3 weeks.
Number of participants with surgical site infection during index hospitalization
大体时间:Postoperative day 1 up to 3 weeks postoperative.
Number of operatively treated participants with surgical site infection during the index hospitalization, defined according to standard clinical and microbiological criteria.
Postoperative day 1 up to 3 weeks postoperative.
Functional mobility at discharge
大体时间:Day 1 (Baseline, Hospital admission) up to 3 weeks.
Functional mobility at discharge, categorized as: independent mobilization, mobilization with assistive devices (e.g. walking frame, crutches), assisted standing or bedbound.
Day 1 (Baseline, Hospital admission) up to 3 weeks.

次要结果测量

结果测量
措施说明
大体时间
Length of index hospital stay
大体时间:Day 1 (Baseline, Hospital admission) up to 3 weeks.
Length of index hospital stay, measured in days
Day 1 (Baseline, Hospital admission) up to 3 weeks.
Discharge destination at hospital discharge
大体时间:At discharge from the index hospital stay, up to 3 weeks
Discharge destination, categorized as: independent at home, community-based support or institutional care (e.g. nursing home, rehabilitation facility)
At discharge from the index hospital stay, up to 3 weeks
In-hospital mortality during the index hospital stay
大体时间:Day 1 (Baseline, Hospital admission) up to 3 weeks.
Number of participants who die during the index hospitalization.
Day 1 (Baseline, Hospital admission) up to 3 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月1日

初级完成 (实际的)

2025年6月1日

研究完成 (实际的)

2025年6月1日

研究注册日期

首次提交

2026年3月23日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • NuTra

药物和器械信息、研究文件

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