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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- 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
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.
- Conditions
- Postoperative Delirium (POD), Hip Fracture, CRP, Albumin, Lymphocyte
- 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 group | Role | What they receive |
|---|---|---|
| Geriatric patients undergoing hip fracture surgery | Patients 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.
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.
- First posted10 Feb 2025
- Study start6 Feb 2025
- Primary completion6 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ERBİL TÜRKSAL, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Erbil Türksal, Specialist, Principal investigator, University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the CRP-Albumin-Lymphocyte (CALLY) Index Effective in Predicting Postoperative Delirium in Geriatric Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT06818409
- Acronym / sponsor ID
- 2024-BÇEK/195
- Conditions
- Postoperative Delirium (POD), Hip Fracture, CRP, Albumin, Lymphocyte
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 6 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patients undergoing hip fracture surgery | – | Diagnostic Test: The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosisPatients aged >65 years undergoing hip fracture surgery during the study period |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients aged 65 years and older who undergo surgery for femoral neck or intertrochanteric fractures
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Diagnostic and Statistical Manual of Mental Disorders (DSM) - 5 criteria for delirium diagnosisDelirium presence will be assessed using DSM-5 criteria twice daily (morning and evening) for three days, after surgery. | Diagnostic test | Geriatric patients undergoing hip fracture surgery |
Primary outcome
Postoperative delirium
Time frame: Twice daily (morning and evening) for three days
Delirium presence will be assessed using DSM-5 criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erbil Türksal, Specialist principal investigator
University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
1 site in 1 country: see every site and its status.
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.