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Completed

NCT Number: NCT07582575

Nutrition and Trauma - 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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Trauma and Reconstructive Surgery, University of Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day

Dietary Supplement

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.

Primary outcomes

  1. Number of participants with medical complications during index hospitalization

    Time frame: 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.

  2. Number of participants with surgical site infection during index hospitalization

    Time frame: 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.

  3. Functional mobility at discharge

    Time frame: 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.

Secondary outcomes

  1. Length of index hospital stay

    Time frame: Day 1 (Baseline, Hospital admission) up to 3 weeks.

    Length of index hospital stay, measured in days

  2. Discharge destination at hospital discharge

    Time frame: 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)

  3. In-hospital mortality during the index hospital stay

    Time frame: Day 1 (Baseline, Hospital admission) up to 3 weeks.

    Number of participants who die during the index hospitalization.

Sponsors and collaborators

Lead sponsor

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu

Other

Registry information

Official study title

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

Acronym: NuTra

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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