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Postoperative Delirium (POD)NCT06818409

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

An observational study of Postoperative Delirium (POD) and Hip Fracture, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Delirium (POD), Hip Fracture, CRP
What is being tested?
The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosis
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Feb 2025to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients with a BMI <18.5 or ≥35
  • Patients with chronic organ failure
  • Patients with advanced-stage cancer

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ERBİL TÜRKSAL, Specialist contact

530 228 1319 ext. +90

drerbilturksal@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

    Ankara, Keçiören, 06290

    Erbil Türksal, Specialist, 530 228 1319 ext. +90, drerbilturksal@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Being tested
The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosis
Medical subject headings
Emergence Delirium, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT06818409
Study groupRoleWhat they receive
Geriatric patients undergoing hip fracture surgeryPatients aged >65 years undergoing hip fracture surgery during the study period
Receives: Diagnostic Test: The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative delirium

    Delirium presence will be assessed using DSM-5 criteria

    Measured: Twice daily (morning and evening) for three days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start6 Feb 2025
  3. Primary completion6 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06818409
Sponsor's protocol ID
2024-BÇEK/195
Status last verified
Feb 2025
First submitted
5 Feb 2025
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Delirium (POD) and Hip Fracture, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ERBİL TÜRKSAL, Specialist (530 228 1319 ext. +90, drerbilturksal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative delirium (time frame: Twice daily (morning and evening) for three days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

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