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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Tübingen, Tyskland, 72076
- Department of Trauma and Reconstructive Surgery, University of Tuebingen
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Ingen inngripen: 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
|
|
|
Ingen inngripen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with medical complications during index hospitalization
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of index hospital stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NuTra
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .