DeliriumNCT07741175
Evaluation of the Efficiency of Neutrophil-Lymphocyte Ratio in Predicting Delirium in Geriatric Patients Undergoing Hip Fracture Surgery
An observational study of Delirium and Elderly Patient, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Aim: Postoperative delirium (POD) is one of the most common complications in elderly patients and is associated with increased morbidity, mortality, length of hospital stay and medical care costs. One of the mechanisms proposed for the pathophysiology of delirium is neuroinflammatory processes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Elderly Patient, Hip Fracture Surgery
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Feb 2022to 27 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Older adult
Study population: Patients aged 65 and over, with a Mini Mental Test (MMT) score of 24 and above, who would undergo hip fracture surgery, who -or their legal guardian- could give voluntary consent, with ASA scores of I-IV.
Who may be able to join
- Patients aged 65 and over
- Patients who will undergo hip fracture surgery
- Patients who or their relatives can give voluntary consent
- ASA I-IV patients
- Patients with a Preoperative Mini Mental Test (MMT) score of 24 and above
Who cannot join
- Under 65 years old
- Patients who did not agree to participate in the study
- Unconscious
- Patients with a preoperative Mini Mental Test (MMT) score below 24
- Visually, hearing and speech impaired
- Chronic alcohol user
Show all 11Show fewer
- Patients with cognitive or psychiatric disorders such as known dementia, Parkinson's, Alzheimer's
- Patients who need postoperative mechanical ventilation support
- A history of acute myocardial infarction in the last 6 months
- Patients with chronic renal failure undergoing regular dialysis
- Patients using oxygen concentrators at home
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ali Emre Karakis
Ankara, 06200
Dr. Abdurrahman Yurtaslan OTRH
Ankara
About this study
Aim:
Postoperative delirium (POD) is one of the most common complications in elderly patients and is associated with increased morbidity, mortality, length of hospital stay and medical care costs. One of the mechanisms proposed for the pathophysiology of delirium is neuroinflammatory processes. The neutrophil-lymphocyte ratio (NLR) is a cost-effective and easily applicable marker of inflammation and oxidative stress. NLR has been used to predict complications, determine prognosis and evaluate mortality in various patient groups and diseases. Most of the studies investigating the relationship between NLR and postoperative delirium in the elderly patient group undergoing hip fracture surgery are retrospective, and the number of prospective studies with large case-series is insufficient. In this study, the investigators aimed to evaluate the effectiveness of NLR in predicting postoperative delirium in elderly patients undergoing hip fracture surgery.
Read the detailed description
Materials and Methods:
Our study is a single-center, prospective, observational study. Our study included 100 patients aged 65 and over, with a Mini Mental Test (MMT) score of 24 and above, who would undergo hip fracture surgery, who -or their legal guardian- could give voluntary consent, with ASA scores of I-IV. Routine preoperative anesthesia evaluation of all patients was performed, and age, gender, type of hip fracture and the surgical procedure to be performed, the degree of kinship with the people they co-live and those who will accompany them in the hospital, height, weight, body mass index (BMI), level of education, existing comorbid diseases, presence of pressure ulcers, history of smoking and alcohol use, medications taken routinely, American Society of Anesthesiologists (ASA) score, and length of preoperative hospital stay were recorded. The patients' basic cognitive functions were evaluated by utilizing the Mini Mental Test (MMT) at the preoperative visit. The routine preoperative blood tests of the patients, including leukocyte, neutrophil, lymphocyte, hemoglobin, hematocrit, platelet, glucose, BUN (blood urea nitrogen), creatinine, albumin, sodium, potassium, liver function tests, C-reactive protein (CRP), and procalcitonin results were recorded. Preoperative NLR was calculated. NLR was calculated as the ratio of neutrophil count to lymphocyte count. Postoperative delirium occurrence was evaluated using the Confusion Assessment Method (CAM) twice a day in the first 3 postoperative days. The place where the delirium developed (postoperative intensive care unit or ward), the time when delirium developed, and the type of delirium were recorded in patients diagnosed with postoperative delirium by CAM. NLR was calculated and recorded from the routine hemogram results taken at the 1st, 16th and 24th hours in the postoperative period. In addition, the postoperative hospital stay of the patients was recorded.
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients aged 65 and over, with a Mini Mental Test (MMT) score of 24 and above, who would undergo hip fracture surgery, who -or their legal guardian- could give voluntary consent, with ASA scores of I-IV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium Incidence
Incidence and clinical features of postoperative delirium evaluated using the Confusion Assessment Method (CAM) algorithm. The CAM algorithm assesses four domain features: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium requires the presence of features 1 and 2, plus either feature 3 or 4
Measured: Twice daily during the first 3 postoperative days
Secondary outcomes (2)
Neutrophil-to-Lymphocyte Ratio (NLR) Changes
Assessment of NLR values calculated as absolute neutrophil count divided by absolute lymphocyte count derived from routine complete blood counts
Measured: Baseline (preoperative), and at 1 hour, 16 hours, and 24 hours postoperatively first day
Preoperative Cognitive Function
Evaluation of baseline cognitive functions using the Mini Mental State Examination (MMSE/MMT) score (range 0-30)
Measured: Baseline (preoperative evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start24 Feb 2022
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Emre Karakis, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Dilek Kalayci, Study director, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741175
- Sponsor's protocol ID
- 2022-02/1680
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He R, Wang F, Shen H, Zeng Y, LijuanZhang. Association between increased neutrophil-to-lymphocyte ratio and postoperative delirium in elderly patients with total hip arthroplasty for hip fracture. BMC Psychiatry. 2020 Oct 7;20(1):496. doi: 10.1186/s12888-020-02908-2.
PubMed 33028273
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Neutrophil-Lymphocyte Ratio in Predicting Delirium in Geriatric Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT07741175
- Acronym / sponsor ID
- 2022-02/1680
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 3 Aug 2026 (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.
Aim:
Postoperative delirium (POD) is one of the most common complications in elderly patients and is associated with increased morbidity, mortality, length of hospital stay and medical care costs. One of the mechanisms proposed for the pathophysiology of delirium is neuroinflammatory processes. The neutrophil-lymphocyte ratio (NLR) is a cost-effective and easily applicable marker of inflammation and oxidative stress. NLR has been used to predict complications, determine prognosis and evaluate mortality in various patient groups and diseases. Most of the studies investigating the relationship between NLR and postoperative delirium in the elderly patient group undergoing hip fracture surgery are retrospective, and the number of prospective studies with large case-series is insufficient. In this study, the investigators aimed to evaluate the effectiveness of NLR in predicting postoperative delirium in elderly patients undergoing hip fracture surgery.
Detailed description
Materials and Methods:
Our study is a single-center, prospective, observational study. Our study included 100 patients aged 65 and over, with a Mini Mental Test (MMT) score of 24 and above, who would undergo hip fracture surgery, who -or their legal guardian- could give voluntary consent, with ASA scores of I-IV. Routine preoperative anesthesia evaluation of all patients was performed, and age, gender, type of hip fracture and the surgical procedure to be performed, the degree of kinship with the people they co-live and those who will accompany them in the hospital, height, weight, body mass index (BMI), level of education, existing comorbid diseases, presence of pressure ulcers, history of smoking and alcohol use, medications taken routinely, American Society of Anesthesiologists (ASA) score, and length of preoperative hospital stay were recorded. The patients' basic cognitive functions were evaluated by utilizing the Mini Mental Test (MMT) at the preoperative visit. The routine preoperative blood tests of the patients, including leukocyte, neutrophil, lymphocyte, hemoglobin, hematocrit, platelet, glucose, BUN (blood urea nitrogen), creatinine, albumin, sodium, potassium, liver function tests, C-reactive protein (CRP), and procalcitonin results were recorded. Preoperative NLR was calculated. NLR was calculated as the ratio of neutrophil count to lymphocyte count. Postoperative delirium occurrence was evaluated using the Confusion Assessment Method (CAM) twice a day in the first 3 postoperative days. The place where the delirium developed (postoperative intensive care unit or ward), the time when delirium developed, and the type of delirium were recorded in patients diagnosed with postoperative delirium by CAM. NLR was calculated and recorded from the routine hemogram results taken at the 1st, 16th and 24th hours in the postoperative period. In addition, the postoperative hospital stay of the patients was recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients aged 65 and over, with a Mini Mental Test (MMT) score of 24 and above, who would undergo hip fracture surgery, who -or their legal guardian- could give voluntary consent, with ASA scores of I-IV. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and over, with a Mini Mental Test (MMT) score of 24 and above, who would undergo hip fracture surgery, who -or their legal guardian- could give voluntary consent, with ASA scores of I-IV.
Key inclusion criteria (5 listed)
- Patients aged 65 and over
- Patients who will undergo hip fracture surgery
- Patients who or their relatives can give voluntary consent
- ASA I-IV patients
- Patients with a Preoperative Mini Mental Test (MMT) score of 24 and above
Key exclusion criteria (11 listed)
- Under 65 years old
- Patients who did not agree to participate in the study
- Unconscious
- Patients with a preoperative Mini Mental Test (MMT) score below 24
- Visually, hearing and speech impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Delirium Incidence
Time frame: Twice daily during the first 3 postoperative days
Incidence and clinical features of postoperative delirium evaluated using the Confusion Assessment Method (CAM) algorithm. The CAM algorithm assesses four domain features: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium requires the presence of features 1 and 2, plus either feature 3 or 4
2 secondary outcomes
Neutrophil-to-Lymphocyte Ratio (NLR) Changes
Time frame: Baseline (preoperative), and at 1 hour, 16 hours, and 24 hours postoperatively first day
Preoperative Cognitive Function
Time frame: Baseline (preoperative evaluation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 33028273He R, Wang F, Shen H, Zeng Y, LijuanZhang. Association between increased neutrophil-to-lymphocyte ratio and postoperative delirium in elderly patients with total hip arthroplasty for hip fracture. BMC Psychiatry. 2020 Oct 7;20(1):496. doi: 10.1186/s12888-020-02908-2.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Dilek Kalayci study director
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Elderly Patient, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 2 sites 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium Incidence (time frame: Twice daily during the first 3 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07741175, which also lists 1 linked publication.
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 3 Aug 2026.