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

May 19, 2026 updated by: Özlem Ersoy Karka, Duzce University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Düzce, Turkey (Türkiye)
        • Recruiting
        • Duzce University Health Research Center
        • Contact:
          • Ozlem Ersoy Karka, Ass.Prof.
        • Contact:
          • Gizem Önemli, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward.
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)
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.
Group 2: Patients followed with routine dietary intake without additional nutritional support.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
perioperatively/periprocedurally

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Mortality recorded during hospitalization and follow-up visits
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.
Duration of ICU stay in days.
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.
Total days from admission to discharge.
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.
Change in arm and waist circumference as indicators of nutritional status.
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.
Albumin values obtained from routine laboratory tests.
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
Incidence of hypotension, bradycardia, and inotrope requirement.
perioperatively/periprocedurally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duzce University

Investigators

  • Study Chair: Özlem Ersoy Karka, Ass. Prof., Duzce University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drozlemersoy8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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