Malnutitrion
Conditions
Keywords
randomised controlled interventional study
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProtein-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.
Sponsors
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized controlled parallel-group interventional study comparing structured nutritional management with standard care in geriatric trauma patients.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with medical complications during index hospitalization | 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. |
| Number of participants with surgical site infection during index hospitalization | 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. |
| Functional mobility at discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of index hospital stay | Day 1 (Baseline, Hospital admission) up to 3 weeks. | Length of index hospital stay, measured in days |
| Discharge destination at hospital discharge | 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) |
| In-hospital mortality during the index hospital stay | Day 1 (Baseline, Hospital admission) up to 3 weeks. | Number of participants who die during the index hospitalization. |
Countries
Germany
Outcome results
None listed