NCT06473324

Brief Summary

This retrospective study aims to collect electronic medical record data from Dandong central hospital spanning from January 2013 to November 2023. The collected data does not contain any personally identifiable information or breach privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The research aims to investigate the correlation between preoperative blood glucose levels in elderly hip fracture patients and postoperative delirium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,031

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 18, 2024

Last Update Submit

June 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Postoperative Delirium

    Postoperative Delirium (POD) manifests as acute cognitive dysfunction and consciousness disorder, characterized by changes in attention or consciousness that cannot be attributed to pre-existing cognitive impairments. Typical symptoms include hallucinations, delusions, agitated behavior, disordered speech, decreased attention, confusion, unclear consciousness, and disrupted sleep-wake cycles. Moreover, POD typically occurs within the first five days after surgery, particularly within the initial 48 hours, and exhibits significant fluctuations.

    up to 2 months

Study Arms (2)

hyperglycaemia group

Blood glucose level ≥ 6.1 mmol/L

hypoglycaemic group

Blood glucose level \< 6.1 mmol/L

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 2,031 electronic medical records were gathered. Following stringent inclusion and exclusion criteria, a retrospective cohort study was conducted on 1,440 patients with hip fracture. Among them, 783 patients (54.4%) exhibited preoperative persistent hyperglycemia (serum glucose levels ≥ 6.1 mmol/L on multiple occasions), while 275 patients (19.1%) experienced postoperative delirium. The average age of the included geriatric hip fracture patients was 74.7 ± 9.8 years, with males comprising 39.7% of the sample.

You may qualify if:

  • \) Patients who have undergone surgical treatment for hip fractures.

You may not qualify if:

  • Multiple or pathological hip fractures.
  • Emergent surgery.
  • Age below 60 years.
  • Incomplete electronic medical records or preoperative blood glucose levels were assessed fewer than two times.
  • Presence of neurological and psychiatric disorders, except dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dandong Central Hospital

Dandong, Liaoning, 118002, China

Location

Related Publications (1)

  • Wang W, Zhang Y, Yao W, Tang W, Li Y, Sun H, Ding W. Association between preoperative persistent hyperglycemia and postoperative delirium in geriatric hip fracture patients. BMC Geriatr. 2024 Jul 8;24(1):585. doi: 10.1186/s12877-024-05192-x.

MeSH Terms

Conditions

Emergence DeliriumHip FracturesHyperglycemia

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 25, 2024

Study Start

November 21, 2023

Primary Completion

January 1, 2024

Study Completion

January 3, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations