Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorDuzce University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients requiring preoperative intensive care
Patients unable to tolerate enteral nutrition
Patients with advanced liver or kidney failure
Patients unable to cooperate
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Oral Nutritional Supplement (ONS)
Dietary supplementStandard 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.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward.1 intervention
Group B: Group 2: Patients followed with routine dietary intake without additional nutritional support.0 interventions
Trial outcomes
Primary outcomes
1
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/periprocedurallySecondary outcomes
1
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 days2
All-Cause Mortality
Mortality recorded during hospitalization and follow-up visits
Time frame
During hospital stay, and at postoperative 30 and 90 days3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov