An observational study in Femoral Fractures, Frailty and Malnutrition, sponsored by Duzce University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Duzce University · Observational
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:
Researchers will compare patients who receive preoperative oral nutrition support with those who follow routine nutrition.
Participants will:
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.
186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.
This study's planned enrollment of 228 is above the median of 100 across 67 observational studies indexed under Femoral Fractures.
Browse Femoral Fractures studies →Duzce University is the lead sponsor of 76 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of elderly patients aged 65 years or older with femur fractures and a high frailty index (Clinical Frailty Scale ≥5) who are admitted for surgery at Düzce University Faculty of Medicine Hospital and are expected to require postoperative intensive care. Patients receiving preoperative oral nutritional support as part of routine clinical practice and those continuing their usual diet will be observed and followed perioperatively and postoperatively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elderly patients with femur fractures and high frailty who receive preoperative oral nutritional supplements in the orthopedic ward according to routine nutrition clinic recommendations. Patients are followed perioperatively and postoperatively for hemodynamic stability, complications, and mortality.
Dietary Supplement: Oral Nutritional Supplement (ONS)
Elderly patients with femur fractures and high frailty who continue their usual diet without additional nutritional support before surgery. Patients are followed with the same perioperative and postoperative outcome measurements for comparison.
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.
Change in Pleth Variability Index (ΔPVI)
PVI values recorded with finger-probe noninvasive hemodynamic monitoring; ΔPVI will be calculated across predefined perioperative time points as an indicator of hemodynamic stability.
Time frame: perioperatively/periprocedurally
Postoperative Morbidity Rate
Incidence of postoperative complications recorded during ICU and ward follow-up.
Time frame: During hospital stay, and at postoperative 30 and 90 days
All-Cause Mortality
Mortality recorded during hospitalization and follow-up visits
Time frame: During hospital stay, and at postoperative 30 and 90 days
ICU Length of Stay
Duration of ICU stay in days.
Time frame: From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.
Total Hospital Length of Stay
Total days from admission to discharge.
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)
Change in arm and waist circumference as indicators of nutritional status.
Time frame: Baseline (Day 1 of hospitalization) and at hospital discharge during the index hospitalization, assessed up to 90 days.
Serum Albumin Level Change
Albumin values obtained from routine laboratory tests.
Time frame: Baseline (Day 1 of hospitalization) and preoperative period (within 24 hours before surgery), assessed up to 90 days.
Intraoperative Hemodynamic Events
Incidence of hypotension, bradycardia, and inotrope requirement.
Time frame: perioperatively/periprocedurally
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.
Of 29 observational studies under Femoral Fractures, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 9 months is below that.
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Duzce University