Nutrition and Trauma - The Influence of Malnutrition in Geriatric Trauma Patients

NCT07582575 | Completed

• 1 other identifier: NuTra
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutitrion

Keywords

randomised controlled interventional study

Outcome Measures

Primary Outcomes (3)

• Number of participants with medical complications during index hospitalization

  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

  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

  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.

Secondary Outcomes (3)

• Length of index hospital stay

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

• Discharge destination at hospital discharge

  At discharge from the index hospital stay, up to 3 weeks

• In-hospital mortality during the index hospital stay

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

Study Arms (3)

Group A Intervention

EXPERIMENTAL

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

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

Group B Control

NO INTERVENTION

Patients in the malnourished control group (B) received standard hospital whole food diet without targeted protein enrichment or routine provision of oral nutritional supplements

Group C Control

NO INTERVENTION

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

Interventions

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.

Group A Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Department of Trauma and Reconstructive Surgery, University of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (13)

• Krupp S, Freiberger E, Renner C, Hofmann W. [Assessment of mobility/motor skills in old age : Based on the S1 guideline "Geriatric assessment level 2, living guideline"]. Z Gerontol Geriatr. 2022 May;55(3):239-248. doi: 10.1007/s00391-022-02060-4. Epub 2022 Apr 20. German.

  PMID: 35441870 BACKGROUND

• Rapp K, Rothenbacher D, Magaziner J, Becker C, Benzinger P, Konig HH, Jaensch A, Buchele G. Risk of Nursing Home Admission After Femoral Fracture Compared With Stroke, Myocardial Infarction, and Pneumonia. J Am Med Dir Assoc. 2015 Aug 1;16(8):715.e7-715.e12. doi: 10.1016/j.jamda.2015.05.013. Epub 2015 Jul 2.

  PMID: 26142060 BACKGROUND

• Schoeneberg C, Knobe M, Babst R, Friess T, Volland R, Hartwig E, Schmidt W, Lendemans S, Buecking B; AltersTraumaRegister DGU. [120-day follow-up after proximal femoral fractures-first results from the Geriatric Trauma Registry DGU(R)]. Unfallchirurg. 2020 May;123(5):375-385. doi: 10.1007/s00113-019-00730-4. German.

  PMID: 31598740 BACKGROUND

• Arkley J, Dixon J, Wilson F, Charlton K, Ollivere BJ, Eardley W. Assessment of Nutrition and Supplementation in Patients With Hip Fractures. Geriatr Orthop Surg Rehabil. 2019 Oct 17;10:2151459319879804. doi: 10.1177/2151459319879804. eCollection 2019.

  PMID: 31667002 BACKGROUND

• Irisawa H, Mizushima T. Relationship between Nutritional Status, Body Composition, Muscle Strength, and Functional Recovery in Patients with Proximal Femur Fracture. Nutrients. 2022 May 30;14(11):2298. doi: 10.3390/nu14112298.

  PMID: 35684096 BACKGROUND

• Bucking B, Neuerburg C, Knobe M, Liener U. [Treatment of patients with fragility fractures]. Unfallchirurg. 2019 Oct;122(10):755-761. doi: 10.1007/s00113-019-00707-3. German.

  PMID: 31428807 BACKGROUND

• Kammerlander C, Blauth M, Gosch M, Bocker W. [Co-management in geriatric traumatology]. Orthopade. 2015 Sep;44(9):681-685. doi: 10.1007/s00132-015-3144-6. German.

  PMID: 26205359 BACKGROUND

• Berk T, Thalmann M, Jensen KO, Schwarzenberg P, Jukema GN, Pape HC, Halvachizadeh S. Implementation of a novel nursing assessment tool in geriatric trauma patients with proximal femur fractures. PLoS One. 2023 Jun 9;18(6):e0284320. doi: 10.1371/journal.pone.0284320. eCollection 2023.

  PMID: 37294793 BACKGROUND

• Becker N, Hafner T, Pishnamaz M, Hildebrand F, Kobbe P. Patient-specific risk factors for adverse outcomes following geriatric proximal femur fractures. Eur J Trauma Emerg Surg. 2022 Apr;48(2):753-761. doi: 10.1007/s00068-022-01953-8. Epub 2022 Mar 24.

  PMID: 35325262 BACKGROUND

• Walter N, Rupp M, Lang S, Alt V. The epidemiology of fracture-related infections in Germany. Sci Rep. 2021 May 17;11(1):10443. doi: 10.1038/s41598-021-90008-w.

  PMID: 34001973 BACKGROUND

• Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.

  PMID: 29710860 BACKGROUND

• Gumieiro DN, Rafacho BP, Goncalves AF, Tanni SE, Azevedo PS, Sakane DT, Carneiro CA, Gaspardo D, Zornoff LA, Pereira GJ, Paiva SA, Minicucci MF. Mini Nutritional Assessment predicts gait status and mortality 6 months after hip fracture. Br J Nutr. 2013 May;109(9):1657-61. doi: 10.1017/S0007114512003686. Epub 2012 Sep 28.

  PMID: 23017491 BACKGROUND

• Rupp M, Walter N, Pfeifer C, Lang S, Kerschbaum M, Krutsch W, Baumann F, Alt V. The Incidence of Fractures Among the Adult Population of Germany-an Analysis From 2009 through 2019. Dtsch Arztebl Int. 2021 Oct 8;118(40):665-669. doi: 10.3238/arztebl.m2021.0238.

  PMID: 34140088 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized controlled parallel-group interventional study comparing structured nutritional management with standard care in geriatric trauma patients.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

DE (1)