Perioperative ComplicationsPDCEPNCT04911530
Perioperative Database of Chinese Elderly Patients
An observational study of Perioperative Complications and Perioperative/Postoperative Complications, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The investigators aim to establish a prospective database of perioperative elderly patients from multiple regions and centers. Collected data involves postoperative complications of the central nervous system, cardiovascular system, kidney, respiratory system, infection, pain, and other perioperative complications. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Complications, Perioperative/Postoperative Complications, Perioperative Adverse Events
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 2025
- 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: Hospital-based, elderly patients, perioperative/postoperative outcome/complications study
Who may be able to join
- Geriatric surgical patients ≥65 years old, undergoing elective surgery with a planned overnight hospital stay following surgery.
Who cannot join
- Patients fully refused to participate in the study;
- Patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status were excluded;
- Patients whose surgeries were canceled;
- Patients accepted cardiac surgeries were excluded from the heart injury section;
- Patients accepted cardiac, neurosurgeries or were excluded from postoperative central nervous system and pain observation section;
- Patients refused to participate in neurocognitive, anxiety, depression, or pain questionnaire were excluded from relative assessment and measurement.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Weidong Mi, PhD, 8613381082966, wwdd1962@aliyun.com
Jingsheng Lou, PhD, 8613811065322, loujingsheng@163.com
About this study
The investigators aim to establish a prospective database of perioperative elderly patients from multiple regions and centers. Collected data involves postoperative complications of the central nervous system, cardiovascular system, kidney, respiratory system, infection, pain, and other perioperative complications. Based on the database, the investigators intend to explore:
- The incidence and risk factors of perioperative morbidity and mortality in elderly patients;
- Perioperative risk assessment methods and early warning models for elderly patients;
- Practical, safe, and effective risk prevention and control system through subsequent studies.
Read the detailed description
As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. The incidence of postoperative complications is twice that of non-elderly patients, and mortality rates are five times higher than non-elderly patients. Thus, it is a significant challenge to safely and stably ensure the elderly are in an optimal perioperative period.
For the good of optimizing perioperative management, it is urgent to build a large-sample, multi-center database. Based on this database, the investigators can explore new risk assessment methods and establish a perioperative risk prediction model and early warning system suitable for elderly patients. It will help improve this group of patients' short- and long-term outcomes and thus reduce the economic burden of national health and medical resources.
In this context, establishing a clinical database including data for all perioperative elderly patients is of high interest. This database will allow the investigators to carry out clinical research on:
- Clinical, biological, and genetic factors predictive of perioperative complications and deaths;
- Systematic and individualized evaluation tools for elderly patients;
- Prognostic factors for improving short- and long-term outcomes. This is particularly significant for rare clinical evidence of perioperative elderly patients for which the current knowledge is scarce.
The database will also allow the investigators to develop or participate in multi-center trials, national or international, and facilitate the formation of perioperative data collection standards.
- Conditions
- Perioperative Complications, Perioperative/Postoperative Complications, Perioperative Adverse Events
- Being tested
- no intervention
- Keywords
- central nervous system complications, heart injury, acute kidney injury, lung injury, infection, pain
- Medical subject headings
- Postoperative Complications, Heart Injuries, Acute Kidney Injury, Lung Injury, Infections, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| elderly patients (aged ≥ 65 years) | elderly patients undergo surgeries Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Clinical data of postoperative complications in the medical record and follow-up update. Postoperative complications, including central nervous system injury, heart injury, acute kidney injury, lung injury, infection, and pain.
Measured: Up to 30 days
Postoperative Survival
Clinical data of survival in the medical record and follow-up update.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion31 Dec 2025 (estimated)
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 Perioperative ComplicationsStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, PhD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911530
- Sponsor's protocol ID
- PLAGH-AOC-001
- Acronym
- PDCEP
- Status last verified
- May 2023
- First submitted
- 28 Mar 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han S, Li F, Hou D, Lv X, Zhang H, Xiao S, Lou J, Li H, Cao J, Wang D, Gu X, Peng Y, Xie Y, Feng Y, Wu Q, Xu J, Mi W, Liu Y. Preoperative health status assessed with different scales and postoperative cardiac and cerebrovascular complications in older patients: A retrospective study of a large multicentre cohort. Eur J Anaesthesiol. 2026 Jul 7. doi: 10.1097/EJA.0000000000002432. Online ahead of print.
PubMed 42411380
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Database of Chinese Elderly Patients
- ClinicalTrials.gov ID
- NCT04911530
- Acronym / sponsor ID
- PDCEP / PLAGH-AOC-001
- Conditions
- Perioperative Complications, Perioperative/Postoperative Complications, Perioperative Adverse Events
- Keywords
- central nervous system complications, heart injury, acute kidney injury, lung injury, infection, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2021 (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.
The investigators aim to establish a prospective database of perioperative elderly patients from multiple regions and centers. Collected data involves postoperative complications of the central nervous system, cardiovascular system, kidney, respiratory system, infection, pain, and other perioperative complications. Based on the database, the investigators intend to explore:
- The incidence and risk factors of perioperative morbidity and mortality in elderly patients;
- Perioperative risk assessment methods and early warning models for elderly patients;
- Practical, safe, and effective risk prevention and control system through subsequent studies.
Detailed description
As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. The incidence of postoperative complications is twice that of non-elderly patients, and mortality rates are five times higher than non-elderly patients. Thus, it is a significant challenge to safely and stably ensure the elderly are in an optimal perioperative period.
For the good of optimizing perioperative management, it is urgent to build a large-sample, multi-center database. Based on this database, the investigators can explore new risk assessment methods and establish a perioperative risk prediction model and early warning system suitable for elderly patients. It will help improve this group of patients' short- and long-term outcomes and thus reduce the economic burden of national health and medical resources.
In this context, establishing a clinical database including data for all perioperative elderly patients is of high interest. This database will allow the investigators to carry out clinical research on:
- Clinical, biological, and genetic factors predictive of perioperative complications and deaths;
- Systematic and individualized evaluation tools for elderly patients;
- Prognostic factors for improving short- and long-term outcomes. This is particularly significant for rare clinical evidence of perioperative elderly patients for which the current knowledge is scarce.
The database will also allow the investigators to develop or participate in multi-center trials, national or international, and facilitate the formation of perioperative data collection standards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients (aged ≥ 65 years) | – | Other: no interventionelderly patients undergo surgeries |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospital-based, elderly patients, perioperative/postoperative outcome/complications study
Key inclusion criteria (1 listed)
- Geriatric surgical patients ≥65 years old, undergoing elective surgery with a planned overnight hospital stay following surgery.
Key exclusion criteria (6 listed)
- Patients fully refused to participate in the study;
- Patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status were excluded;
- Patients whose surgeries were canceled;
- Patients accepted cardiac surgeries were excluded from the heart injury section;
- Patients accepted cardiac, neurosurgeries or were excluded from postoperative central nervous system and pain observation section;
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 |
|---|---|---|
| no interventionno intervention | Other | elderly patients (aged ≥ 65 years) |
Primary outcome
Postoperative complications
Time frame: Up to 30 days
Clinical data of postoperative complications in the medical record and follow-up update. Postoperative complications, including central nervous system injury, heart injury, acute kidney injury, lung injury, infection, and pain.
Postoperative Survival
Time frame: Up to 30 days
Clinical data of survival in the medical record and follow-up update.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 42411380Han S, Li F, Hou D, Lv X, Zhang H, Xiao S, Lou J, Li H, Cao J, Wang D, Gu X, Peng Y, Xie Y, Feng Y, Wu Q, Xu J, Mi W, Liu Y. Preoperative health status assessed with different scales and postoperative cardiac and cerebrovascular complications in older patients: A retrospective study of a large multicentre cohort. Eur J Anaesthesiol. 2026 Jul 7. doi: 10.1097/EJA.0000000000002432. Online ahead of print.
- 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.
Weidong Mi, PhD study chair
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 Perioperative Complications and Perioperative/Postoperative Complications, 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 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Mi, PhD (8613381082966, wwdd1962@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Up to 30 days). The study lists 2 primary outcomes in all. 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 NCT04911530, 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 1 Jun 2023.