Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Nutritional Supplement (ONS).
- Who it may be relevant to
- Registry conditions: Femoral Fractures, Frailty, Malnutrition. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effects of Preoperative Oral Nutritional Support on Hemodynamic Stability, Morbidity, Mortality, and Anthropometric Measurements in Patients With Femur Fractures and High Frailty Index: A Prospective Observational Study
Overview
The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. The main questions it aims to answer are: * Does preoperative nutrition support improve hemodynamic stability during and after surgery? * Does it reduce postoperative complications, mortality, and length of hospital stay? Researchers will compare patients who receive preoperative oral nutrition support with those who follow routine nutrition. Participants will: * Receive routine medical care with or without nutrition support * Have their hemodynamic values, complications, and outcomes recorded during hospitalization * Be followed at 30 and 90 days after surgery for complications and mortality.
Detailed description
Femur fractures in elderly patients with a high frailty index are associated with increased perioperative morbidity and mortality. Malnutrition is common in this population and may worsen hemodynamic instability, delay recovery, and increase postoperative complications. Although nutritional support has been studied in geriatric patients, data specific to frail patients with femur fractures are limited.
This prospective observational study will be conducted at the Düzce University Faculty of Medicine, Department of Anesthesiology and Reanimation, between January 2026 and December 2027. Patients aged 65 years or older with femur fractures and a Clinical Frailty Scale score ≥5 who are scheduled for surgery and expected to require postoperative intensive care will be included. Nutritional status will be assessed using NRS-2002 and Food Quality Score Index questionnaires.
Participants will be observed in two groups according to routine clinical practice: patients receiving preoperative oral nutritional support recommended by the nutrition clinic, and patients continuing their usual diet without additional support. No intervention will be assigned by the investigators.
Hemodynamic parameters will be recorded intraoperatively and during postoperative intensive care and ward follow-up. Anthropometric measurements (arm and waist circumference), laboratory values, morbidity, mortality, ICU length of stay, and total hospital stay will be documented. Patients will also be evaluated at postoperative 30 and 90 days for complications and survival.
The study aims to determine whether preoperative nutritional support is associated with improved hemodynamic stability and reduced morbidity and mortality in frail elderly patients with femur fractures. The results may guide perioperative nutritional strategies in high-risk geriatric surgical populations.
Interventions
- Dietary supplement Oral Nutritional Supplement (ONS)
Standard preoperative oral nutritional supplements recommended by the hospital nutrition clinic are provided to frail elderly patients with femur fractures during their orthopedic ward stay before surgery. Supplements are given according to routine clinical practice and are not assigned by the investigators.
Primary outcome measures
- Change in Pleth Variability Index (ΔPVI) [Time frame: perioperatively/periprocedurally]
Secondary outcome measures (7)
- Postoperative Morbidity Rate [Time frame: During hospital stay, and at postoperative 30 and 90 days]
- All-Cause Mortality [Time frame: During hospital stay, and at postoperative 30 and 90 days]
- ICU Length of Stay [Time frame: From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.]
- Total Hospital Length of Stay [Time frame: From hospital admission to hospital discharge during the index hospitalization, assessed up to 90 days postoperatively.]
- Anthropometric Measurements (Arm and Waist Circumference Change) [Time frame: Baseline (Day 1 of hospitalization) and at hospital discharge during the index hospitalization, assessed up to 90 days.]
- Serum Albumin Level Change [Time frame: Baseline (Day 1 of hospitalization) and preoperative period (within 24 hours before surgery), assessed up to 90 days.]
- Intraoperative Hemodynamic Events [Time frame: perioperatively/periprocedurally]
Eligibility criteria
Inclusion criteria
- Patients aged 65 years or older hospitalized with a diagnosis of femur fracture
- High frailty index (Clinical Frailty Scale ≥ 5)
- Patients expected to require postoperative intensive care
Exclusion criteria
- Patients requiring preoperative intensive care
- Patients unable to tolerate enteral nutrition
- Patients with advanced liver or kidney failure
- Patients unable to cooperate
- Patients with neuromuscular disease
- Patients with severe malnutrition according to NRS-2002 guidelines
- Patients who refuse to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Duzce University Health Research Center — Düzce
Identifiers
NCT: NCT07463352 · drozlemersoy8