Delirium - PostoperativeNCT07673510
Perioperative Antibiotic Exposure and Postoperative Delirium in Older Adults Undergoing Elective Non-cardiac Surgery: A Single-center Prospective Cohort Study
An observational study of Delirium - Postoperative, run by Chinese PLA General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- Perioperative antibiotics exposure
- How many people
- 4,711 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 1 May 2026
- 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: 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.
Who may be able to join
- patients over 65 years old
- patients undergoing elective non-cardiac surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This prospective, observational, single-center cohort analysis was a substudy of the Perioperative Database of Chinese Elderly Patients (PDCEP) study.
- Conditions
- Delirium - Postoperative
- Being tested
- Perioperative antibiotics exposure
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative antibiotics exposureDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic | Not described Receives: Drug: Perioperative antibiotics exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Evaluations are conducted twice a day.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Apr 2020
- Primary completion1 Apr 2022
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 4,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Li, Chinese PLA General Hospital
- Investigators
- Hao Li, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673510
- Sponsor's protocol ID
- ChinaPLAGH_Antibiotic
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Antibiotic Exposure and Postoperative Delirium in Older Adults Undergoing Elective Non-cardiac Surgery: A Single-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07673510
- Acronym / sponsor ID
- ChinaPLAGH_Antibiotic
- Conditions
- Delirium - Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,711 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 29 Jun 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.
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.
Detailed description
This prospective, observational, single-center cohort analysis was a substudy of the Perioperative Database of Chinese Elderly Patients (PDCEP) study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | – | Drug: Perioperative antibiotics exposure |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- patients over 65 years old
- patients undergoing elective non-cardiac surgery
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Perioperative antibiotics exposureAntimicrobial 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). | Drug | Antibiotic |
Primary outcome
Incidence of postoperative delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Evaluations are conducted twice a day.
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 29 Jun 2026.
- 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. This study is not recruiting at the moment.
Hao Li principal investigator
Chinese PLA General 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 Delirium - Postoperative, run by Chinese PLA General Hospital at 1 site in China.
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 2 inclusion and 6 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 29 Jun 2026. 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 China. 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?
Incidence of postoperative delirium (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 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 29 Jun 2026.