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
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Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-02-06
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
65 Years
ALL
Yes
Sponsors
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Ankara Ataturk Sanatorium Training and Research Hospital
OTHER_GOV
Responsible Party
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ERBİL TÜRKSAL
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)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-BÇEK/195
Identifier Type: -
Identifier Source: org_study_id
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