NCT07673510

Brief Summary

This study aimed to characterize the current patterns of perioperative prophylactic antibiotic use and to systematically evaluate the association between different antibiotic classes and the occurrence of POD, thereby providing clinically relevant safety evidence for perioperative antibiotic decision-making and delirium prevention strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 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

April 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative delirium

    Evaluations are conducted twice a day.

    Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Study Arms (1)

Antibiotic

Drug: Perioperative antibiotics exposure

Interventions

Antimicrobial exposure was defined as a record of antibiotic use prior to the occurrence of delirium. Antimicrobials were divided into five non-mutually exclusive groups: beta-lactams (subclasses: first- through fourth-generation cephalosporins, penicillins and carbapenems), nitroimidazoles, glycopeptides, fluoroquinolones, and others (subclasses: aminoglycosides, oxazolidinones, antifungals, lincosamides, macrolides, and fosfomycins).

Antibiotic

Eligibility Criteria

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

The study included older adult patients (aged 65 years) scheduled for elective non-cardiac surgery in the First Medicine Department of the Chinese PLA General Hospital between April 2020 and April 2022, from whom complete medication records were obtained.

You may qualify if:

  • patients over 65 years old
  • patients undergoing elective non-cardiac surgery

You may not qualify if:

  • older adult patients who had history of psychotic disorders
  • history of neurological disease
  • conditions that would make assessments for delirium unreliable
  • preoperative infection
  • severe hepatic and renal dysfunction, minor and intermediate clean-incision surgery
  • missing data exceeding 5%, and no medication records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital, Beijing

Beijing, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Hao Li

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

April 1, 2020

Primary Completion

April 1, 2022

Study Completion

May 1, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations