An observational study in Postoperative Delirium (POD), Hip Fracture and CRP, sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Observational
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:
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.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's planned enrollment of 100 is below the median of 154 across 288 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Ankara Ataturk Sanatorium Training and Research Hospital is the lead sponsor of 36 studies on the registry; 20 are open to participants now.
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In the literature, the preoperative CRP/albumin ratio has been found to have a sensitivity of 94.1% and a specificity of 43.9% (AUC: 3.69) in detecting postoperative delirium. The incidence of postoperative delirium varies between 10% and 70%, depending on the diagnostic criteria used, the population studied, and the type of surgical procedure. Its incidence is higher following vascular, cardiac, and hip fracture surgeries.
In our study, which investigates the predictive value of the CRP-Albumin-Lymphocyte (CALLY) Index in detecting delirium after hip fracture in the geriatric patient population, these literature findings were taken into account. Based on the Sample Size Estimation in Diagnostic Accuracy Studies, with a power of 0.85, a Type I error of 5%, a specificity of 43.9%, and a prevalence of 50%, the required sample size was calculated as 84 patients. Considering a 20% margin of error, it was decided to include 100 patients in the study.
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Exclusion Criteria:
Patients aged \>65 years undergoing hip fracture surgery during the study period
Diagnostic Test: 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.
Postoperative delirium
Delirium presence will be assessed using DSM-5 criteria
Time frame: Twice daily (morning and evening) for three days
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Aug 2025, 6 months after the start.
Of 187 non-industry observational studies under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 6 months is below that.
Counting every sponsor, half of 188 studies reached it within 20 months; a quarter within 10 and three quarters within 40.
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Ankara Ataturk Sanatorium Training and Research Hospital