Is the CRP-Albumin-Lymphocyte (CALLY) Index Effective in Predicting Postoperative Delirium in Geriatric Patients Undergoing Hip Fracture Surgery

NCT ID: NCT06818409

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-06

Study Completion Date

2025-12-31

Brief Summary

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Introduction: Postoperative delirium (POD) is a common complication in elderly surgical patients and is significantly associated with prolonged hospital stays, cognitive impairment, functional decline, and increased mortality rates within 6 to 12 months. Its incidence has been reported to range between 10% and 70%, depending on the diagnostic criteria used, the population studied, and the type of surgical procedure performed. The incidence is particularly higher following vascular, cardiac, and hip fracture surgeries.

According to the 2024 updated guidelines by the European Society of Anaesthesiology and Intensive Care (ESAIC), POD should be screened at least once daily for a minimum of three days, beginning in the post-anesthesia recovery unit, based on the DSM-5 criteria. POD is a complex syndrome associated with various phenotypes and is likely the result of a combination of neuroinflammatory and oxidative stress processes.

Candidate biomarkers for POD include inflammatory parameters (such as interleukins, C-reactive protein \[CRP\], erythrocyte sedimentation rate, and CD68), dopamine receptors, norepinephrine levels, cortisol levels, genetic biomarkers (e.g., apolipoprotein E4), acetylcholinesterase levels, and albumin levels. However, systemic stress can lead to nonspecific activation of the immune system, resulting in a decrease in lymphocyte count.

Although the relationships between CRP, albumin, and lymphocyte count with POD have been individually investigated in the literature, no study has examined the combined effect of these three parameters. Based on this, we aimed to investigate whether the CRP-Albumin-Lymphocyte (CALLY) Index, a novel index not previously reported in the literature, is effective in predicting POD in geriatric patients with hip fractures. The CALLY Index is calculated using the formula: (Albumin × Lymphocyte) / (CRP × 10⁴).

Aim/Hypothesis:

H₀: The CALLY Index cannot predict the risk of postoperative delirium in geriatric patients undergoing hip fracture surgery.

H₁: The CALLY Index can predict the risk of postoperative delirium in geriatric patients undergoing hip fracture surgery.

Material-Methods:

The following data will be recorded for each patient:

* Demographic variables: age, sex, height, weight, and body mass index (BMI)
* American Society of Anesthesiologists (ASA) physical status classification
* Comorbidities and medication use
* Smoking and alcohol consumption history
* Preoperative laboratory parameters: obtained from the hospital information system for CALLY Index calculation
* Perioperative variables: type and duration of anesthesia, duration of surgery, type of surgical procedure, estimated blood loss, blood product transfusion status, and occurrence of intraoperative adverse events
* Postoperative data:
* Ward of admission after surgery (orthopedic ward/intensive care unit)
* Presence of delirium, assessed twice daily (morning and evening) for three days using DSM-5 criteria, starting in the post-anesthesia recovery unit
* Occurrence of postoperative complications
* Length of stay in the intensive care unit
* Total hospital length of stay
* Mortality status

Patients aged 65 years and older who undergo surgery for femoral neck or intertrochanteric fractures will be included in the study. Patients with preoperative delirium, preoperative dementia, pathological or open fractures, systemic or localized infections in the fracture region during the preoperative period, or multiple trauma will be excluded. Additionally, those with a BMI \<18.5 or ≥35 chronic organ failure, or advanced-stage cancer will be excluded from the study.

Detailed Description

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Conditions

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Postoperative Delirium (POD) Hip Fracture CRP Albumin Lymphocyte

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Geriatric patients undergoing hip fracture surgery

Patients aged \>65 years undergoing hip fracture surgery during the study period

The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosis

Intervention Type DIAGNOSTIC_TEST

Delirium presence will be assessed using DSM-5 criteria twice daily (morning and evening) for three days, after surgery.

Interventions

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The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosis

Delirium presence will be assessed using DSM-5 criteria twice daily (morning and evening) for three days, after surgery.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients aged 65 years and older who undergo surgery for femoral neck or intertrochanteric fractures

Exclusion Criteria

* Patients with preoperative delirium
* Patients with preoperative dementia
* Patients with pathological fractures
* Patients with open fractures
* Patients with systemic or localized infections in the fracture region during the preoperative period
* Patients with multiple trauma
* Patients with a BMI \<18.5 or ≥35
* Patients with chronic organ failure
* Patients with advanced-stage cancer
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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ERBİL TÜRKSAL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erbil Türksal, Specialist

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

Locations

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University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ERBİL TÜRKSAL, Specialist

Role: CONTACT

530 228 1319 ext. +90

Facility Contacts

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Erbil Türksal, Specialist

Role: primary

530 228 1319 ext. +90

Other Identifiers

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2024-BÇEK/195

Identifier Type: -

Identifier Source: org_study_id

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