Postoperative older patients with fragility and hip fracture
Conditions
Interventions
Group 1: Fresubin® 2 kcal fibre (Intervention group), is a nutritionally complete, high-calorie (2 kcal/ml), high-protein (20 g per 200 ml bottle) ONS. It is intended for complete or supplementary nut
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with diagnosis of fragility hip fracture undergoing surgical management according to routine clinical practice 2. Patients who are either at risk of malnutrition or already malnourished as defined by a short form Mini Nutritional Assessment score 0-11 and indication for oral nutritional supplementation 3. Body Mass Index >18 and <30 kg/m² 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with diagnosis of subtrochanteric hip fracture 2. Barthel index 8.0 % 7. Patients with Glomerular Filtration Rate less than 30 mL/min. 8. Patients who are diagnosed with mental illness or depression assessed by the investigator as too severe for being suitable to participate in this study 9. Patients with oropharyngeal dysphagia (requiring thickened fluids) 10. Patients receiving medical nutrition interventions (tube feeding, enteral nutrition (ONS) or parenteral nutrition) prior to admission 11. Patients presenting pathological or high-impact fractures (e.g., automotive accidents) 12. Any contraindication or known allergies to any ingredient of the investigational products 13. Patients who are unable to complete the study or deemed unsuitable by the investigator 14. Patients who are participating in another study at the same time or who have participated within the last 4 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Mean change in phase angle from baseline to 12 weeks after hip fracture surgery measured by Bioelectrical Impedance Analysis (expressed in degrees) •Mean change in hand grip strength from baseline to 12 weeks after hip fracture surgery measured in the dominant hand using a handheld dynamometer (expressed in kg) | — |
Secondary
| Measure | Time frame |
|---|---|
| • The number of hospital readmissions until 6 weeks and 12 weeks post-surgery • Length of stay in hospital after hip fracture surgery • Change in nutritional status measured by the Mini Nutritional Assessment - Short Form from screening to 6 weeks and 12 weeks after surgery • Nutritional intake at 6 weeks and 12 weeks measured by 3-day diet food diary (6 weeks and 12 weeks), analyzed using DIETSTAT software including oral nutritional supplement consumption • Nutritional adequacy of calorie and protein intake (defined as the calorie and protein intake expressed as a percentage of the calorie and protein requirement) at 6 weeks, and 12 weeks after surgery • Adherence to ONS intake: The percentage of the prescribed ONS dose that is consumed, as recorded in patient diaries, at week 6-week and 12-week post-surgery • Mean change in Appendicular Skeletal Muscle Mass from baseline to 6 weeks and 12 weeks after surgery measured by Bioelectrical Impedance Analysis (expressed in kilograms) • Mean Change in total body water, extracellular water, intracellular water from baseline to 6 weeks and 12 weeks after surgery measured by Bioelectrical Impedance Analysis (expressed in litres) • Mean Change in fat mass, fat-free mass, body cell mass from baseline to 6 weeks and 12 weeks after surgery measured by Bioelectrical Impedance Analysis (expressed in Kilograms) • Mean change in quadriceps (rectus femoris) muscle thickness and cross-sectional area from baseline to 6 weeks and 12 weeks after surgery measure by ultrasound (expressed in centimeters) • Mean change in phase angle from baseline to 6 weeks after surgery measured by Bioelectrical Impedance Analysis (expressed in degrees) • Mean change in hand grip strength from baseline to 6 weeks after surgery measured in the dominant hand using a handheld dynamometer (expressed in kg) • Percentage of patients with surgical site infection according to the Centers for Disease Control and Prevention's National Healthcare Safety N | — |
Countries
Spain
Contacts
Public ContactGabriel Olveira
Hospital Regional Universitario de Málaga
Outcome results
None listed