NCT07741175

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

March 29, 2023

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Twice daily during the first 3 postoperative days

Secondary Outcomes (2)

  • Neutrophil-to-Lymphocyte Ratio (NLR) Changes

    Baseline (preoperative), and at 1 hour, 16 hours, and 24 hours postoperatively first day

  • Preoperative Cognitive Function

    Baseline (preoperative evaluation)

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ali Emre Karakis

Ankara, 06200, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan OTRH

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Dilek Kalayci

    Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2023

First Posted

August 3, 2026

Study Start

February 24, 2022

Primary Completion

October 27, 2022

Study Completion

October 27, 2022

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations