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Geriatric Hip Fracture mFI-5 for Postoperative ICU Need and 30 Day Mortality

7 novembre 2026 mis à jour par: özge cihangir özek, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Predictive Value of Modified Frailty Index-5 for Postoperative Intensive Care Unit Requirement and 30-Day Mortality in Geriatric Hip Fracture Patients

This prospective, observational, single-center study aims to evaluate the predictive value of the Modified Frailty Index-5 (mFI-5) score on postoperative intensive care unit (ICU) admission requirements and 30-day mortality in geriatric patients undergoing hip fracture surgery. Patients aged 65 and older presenting with a hip fracture will be evaluated preoperatively using the mFI-5 scoring system (assessing diabetes, hypertension, COPD, congestive heart failure, and functional dependence). Intraoperative hemodynamic data, anesthesia type, and transfusion requirements will be documented. Postoperative ICU admission, total hospital stay, and 30-day survival status will be recorded to assess the prognostic capability of preoperative frailty levels.

Aperçu de l'étude

Description détaillée

This single-center, prospective, observational study will be conducted at the Department of Anesthesiology and Reanimation of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, following approval from the Institutional Ethics Committee. The primary objective is to evaluate the predictive value of the preoperative Modified Frailty Index-5 (mFI-5) score on postoperative intensive care unit (ICU) admission requirements and 30-day mortality in geriatric patients undergoing hip fracture surgery.

STUDY TIMELINE AND POPULATION Patient enrollment will take place between June 1, 2026, and January 1, 2027. All patients aged 65 years and older who present to the operating theater with a diagnosis of hip fracture (including femoral neck, intertrochanteric, or subtrochanteric fractures) and are scheduled for surgical treatment will be screened. Written informed consent will be obtained from all eligible patients or their legally authorized representatives in the preoperative period before any study-related procedures are initiated.

PREOPERATIVE ASSESSMENT (FRAILTY EVALUATION)

Prior to being transferred to the operating room, patients will be evaluated in the anesthesia outpatient clinic or the preoperative preparation holding area by a designated investigator. Frailty status will be determined using the Modified Frailty Index-5 (mFI-5), which consists of five distinct clinical criteria based on the patient's medical history:

  1. Presence of diabetes mellitus (regardless of insulin dependence).
  2. Presence of hypertension (requiring pharmacological treatment).
  3. History of Chronic Obstructive Pulmonary Disease (COPD).
  4. History of Congestive Heart Failure (CHF).
  5. Functional dependence status (defined as the need for assistance in performing activities of daily living within the last 30 days).

Each positive criterion will be scored as 1 point, yielding a total cumulative mFI-5 score ranging from 0 (robust/non-frail) to 5 (severely frail).

INTRAOPERATIVE MANAGEMENT AND MONITORING Upon arrival in the operating theater, standard American Society of Anesthesiologists (ASA) monitoring will be established for all patients, including electrocardiography (ECG), peripheral oxygen saturation (SpO2), and non-invasive blood pressure (NIBP). The choice of anesthesia method (general or regional anesthesia) will be decided by the primary attending anesthesia team based on patient comorbidities and clinical indications, and the type of anesthesia will be recorded.

Hemodynamic parameters, specifically systolic blood pressure, diastolic blood pressure, and heart rate, will be documented at 5-minute intervals throughout the operation. Intraoperative hypotension is strictly defined as a decrease of 20% or more from the patient's baseline blood pressure value. Episodes of hypotension will be managed according to standard clinical protocols using intravenous fluid resuscitation and/or vasopressors (e.g., ephedrine). Total intraoperative blood loss and the volume of blood products transfused will also be carefully quantified and recorded.

POSTOPERATIVE FOLLOW-UP AND OUTCOME MEASURES At the conclusion of the surgical procedure, the patient's requirement for intensive care unit (ICU) admission will be evaluated. Postoperative ICU admission will be determined based on standardized institutional clinical protocols, including the presence of hemodynamic instability, the need for mechanical ventilatory support, or the requirement for close invasive monitoring.

Following surgery, patients will be monitored through hospital discharge to determine the total length of hospital stay (measured in days). The primary definitive endpoints-survival status and the 30-day mortality rate-will be evaluated precisely 30 days after the operation. This long-term follow-up data will be retrieved directly from the national electronic hospital information system registries or via structured telephone interviews conducted with the patients or their primary caregivers. All collected variables will be documented in a dedicated case report form for final statistical modeling.

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Kamuran K KOÇYİĞİT ÖZER, MD
  • Numéro de téléphone: 5322082920
  • E-mail: kkcygt@gmail.com

Lieux d'étude

    • Ankara
      • Ankara, Ankara, Turquie (Türkiye), 06200
        • Recrutement
        • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation
        • Contact:
        • Contact:
          • Kamuran K Özer, MD
          • Numéro de téléphone: 05322082920
          • E-mail: kkcygt@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans à 70 ans (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population consists of geriatric patients aged 65 years and older who present to the emergency department or orthopedic clinics of a tertiary training and research hospital and are subsequently admitted to the operating theater for hip fracture surgery.

The cohort will encompass all consecutive eligible patients scheduled for surgical repair of a femoral neck, intertrochanteric, or subtrochanteric fracture under general or regional anesthesia between June 1, 2026, and January 1, 2027.

La description

Inclusion Criteria:

Patients aged 65 years and older. Diagnosed with a hip fracture (including femoral neck, intertrochanteric, or subtrochanteric fractures).

Scheduled to undergo surgical treatment for the hip fracture. Anesthesia management planned under general or regional (spinal/epidural) anesthesia.

American Society of Anesthesiologists (ASA) physical status classification I, II, III, or IV.

Written informed consent provided voluntarily by the patient or their legally authorized representative prior to surgery.

Exclusion Criteria:

Patients under 65 years of age. Presence of high-energy injuries, major head trauma, or multiple trauma (polytrauma).

Patients who are intubated or require mechanical ventilation in the preoperative period.

Pathological fractures secondary to primary bone malignancies or bone metastases (if applicable per protocol).

Refusal to undergo surgery or failure/refusal to provide written informed consent.

Patients with missing 30-day postoperative follow-up data or incomplete medical records.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Geriatric Hip Fracture Patients

Geriatric patients aged 65 years and older who undergo surgical treatment for hip fracture (femoral neck, intertrochanteric, or subtrochanteric fractures) under general or regional anesthesia. All enrolled patients will be evaluated preoperatively using the Modified Frailty Index-5 (mFI-5) score and followed for 30 days postoperatively.

Preoperative frailty assessment using the Modified Frailty Index-5 (mFI-5) in the preoperative period. Standard perioperative care, including general or regional anesthesia tailored to the patient's clinical indications, intraoperative hemodynamic monitoring (every 5 minutes), and standard postoperative follow-up for ICU admission and 30-day mortality.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postoperative Intensive Care Unit (ICU) Admission Rate
Délai: From the end of surgery up to 30 days postoperatively.

he percentage of patients requiring admission to the intensive care unit during the postoperative period based on standardized clinical protocols (e.g., hemodynamic instability, need for mechanical ventilatory support, or close invasive monitoring). The predictive accuracy and optimal cut-off value of the preoperative Modified Frailty Index-5 (mFI-5) score for this outcome will be determined using Receiver Operating Characteristic (ROC) curve analysis, calculating the Area Under the Curve (AUC), sensitivity, and specificity.

From the end of surgery up to 30 days postoperatively.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
30-Day Mortality Rate
Délai: From the day of hospital admission for surgery until official hospital discharge (approximately 30 days).

The total duration of hospitalization measured in days. The association between the preoperative mFI-5 frailty scores and the length of hospital stay will be analyzed to assess the impact of baseline frailty on resource utilization.

From the day of hospital admission for surgery until official hospital discharge (approximately 30 days).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Özge K Cihangir Özek, MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2026

Achèvement primaire (Estimé)

5 mai 2027

Achèvement de l'étude (Estimé)

5 août 2027

Dates d'inscription aux études

Première soumission

7 novembre 2026

Première soumission répondant aux critères de contrôle qualité

7 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Institutional review board restrictions and local data protection regulations (KVKK) prohibit the public sharing of individual participant data to ensure patient privacy. However, de-identified aggregate data and statistical analyses may be made available to qualified researchers upon reasonable collaborative request to the corresponding author.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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