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NCT Number: NCT07463352

Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duzce University Health Research Center

Düzce, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gizem Önemli, Dr.

CONTACT

Ozlem Ersoy Karka, Ass.Prof.

CONTACT

[email protected]

+90 533 729 3978

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Nutritional Supplement (ONS)

Dietary Supplement

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 outcomes

  1. Change in Pleth Variability Index (ΔPVI)

    Time frame: perioperatively/periprocedurally

    PVI values recorded with finger-probe noninvasive hemodynamic monitoring; ΔPVI will be calculated across predefined perioperative time points as an indicator of hemodynamic stability.

Secondary outcomes

  1. Postoperative Morbidity Rate

    Time frame: During hospital stay, and at postoperative 30 and 90 days

    Incidence of postoperative complications recorded during ICU and ward follow-up.

  2. All-Cause Mortality

    Time frame: During hospital stay, and at postoperative 30 and 90 days

    Mortality recorded during hospitalization and follow-up visits

  3. ICU Length of Stay

    Time frame: From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.

    Duration of ICU stay in days.

  4. Total Hospital Length of Stay

    Time frame: From hospital admission to hospital discharge during the index hospitalization, assessed up to 90 days postoperatively.

    Total days from admission to discharge.

  5. 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.

    Change in arm and waist circumference as indicators of nutritional status.

  6. Serum Albumin Level Change

    Time frame: Baseline (Day 1 of hospitalization) and preoperative period (within 24 hours before surgery), assessed up to 90 days.

    Albumin values obtained from routine laboratory tests.

  7. Intraoperative Hemodynamic Events

    Time frame: perioperatively/periprocedurally

    Incidence of hypotension, bradycardia, and inotrope requirement.

Study contacts

Contact information is provided by the study sponsor or research team.

Gizem Merve Önemli, MD

CONTACT

[email protected]

+90 506 892 1804

Özlem Ersoy Karka, Ass. Prof.

CONTACT

[email protected]

+90 533 729 3978

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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