Postoperative MortalityNCT04389008
The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China
An observational study of Postoperative Mortality and Anesthesia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
At present, the elderly population in China has reached 241 million, and there are more than 20 million elderly surgical patients every year, accounting for about 25% of the surgical population. However, there is no research report on the anesthesia related risk factors of death of elderly patients in hospital. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Mortality, Anesthesia, Elderly Patients
- How many people
- 300,000 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2020to 31 Dec 2021
- 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: Since January 2008, all the elderly non-cardiac surgery patients have been treated in these four hospitals in the first medical center of PLA general hospital, henan provincial people's hospital, the second xiangya hospital of central south university, the third xiangya hospital of central south university, and the union medical college hospital affiliated to fujian medical university.
Who may be able to join
- 1.patients larger than 65 years old at the time of surgery 2.Patients hospitalized for surgery between Jua 2008 to April 2020
Who cannot join
- 1.Critical demographic information and course records are inaccurate or missing.
- 2.The outcome could not be determined during the hospitalization. 3.Cardiac surgery patients 4.Patients undergoing surgery under local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China: a Multi-center Retrospective Study Based on Database
At present, the elderly population in China has reached 241 million, and there are more than 20 million elderly surgical patients every year, accounting for about 25% of the surgical population. However, there is no research report on the anesthesia related risk factors of death of elderly patients in hospital. The purpose of this study is to analyze the perioperative data of multicenter database, and to explore the anesthesia related death risk factors of elderly patients with noncardiac surgery in the investigator's country, especially within 24 hours after surgery, so as to help improve the anesthesia management technology of elderly patients during surgery, improve the medical quality of perioperative period, and improve the prognosis of patients.
- Being tested
- no interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
no interventions
| Study group | Role | What they receive |
|---|---|---|
| Postoperative death | Not described Receives: Other: no interventions | |
| Postoperative non-death | Not described Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether death occurred during hospitalization after surgery
Whether death occurred during hospitalization after surgery
Measured: Within 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start31 May 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative MortalityStudies 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
- Retrospective
- Enrolment
- 300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389008
- Sponsor's protocol ID
- PLAGHAOC202001
- Status last verified
- Jun 2021
- First submitted
- 11 May 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China: a Multi-center Retrospective Study Based on Database
- ClinicalTrials.gov ID
- NCT04389008
- Acronym / sponsor ID
- PLAGHAOC202001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 May 2020 (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.
At present, the elderly population in China has reached 241 million, and there are more than 20 million elderly surgical patients every year, accounting for about 25% of the surgical population. However, there is no research report on the anesthesia related risk factors of death of elderly patients in hospital. The purpose of this study is to analyze the perioperative data of multicenter database, and to explore the anesthesia related death risk factors of elderly patients with noncardiac surgery in the investigator's country, especially within 24 hours after surgery, so as to help improve the anesthesia management technology of elderly patients during surgery, improve the medical quality of perioperative period, and improve the prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative death | – | Other: no interventions |
| Postoperative non-death | – | Other: no interventions |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Since January 2008, all the elderly non-cardiac surgery patients have been treated in these four hospitals in the first medical center of PLA general hospital, henan provincial people's hospital, the second xiangya hospital of central south university, the third xiangya hospital of central south university, and the union medical college hospital affiliated to fujian medical university.
Key inclusion criteria (1 listed)
- 1.patients larger than 65 years old at the time of surgery 2.Patients hospitalized for surgery between Jua 2008 to April 2020
Key exclusion criteria (2 listed)
- 1.Critical demographic information and course records are inaccurate or missing.
- 2.The outcome could not be determined during the hospitalization. 3.Cardiac surgery patients 4.Patients undergoing surgery under local anesthesia
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 interventionsno interventions | Other | Postoperative death, Postoperative non-death |
Primary outcome
Whether death occurred during hospitalization after surgery
Time frame: Within 30 days after discharge
Whether death occurred during hospitalization after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Mortality and Anesthesia, 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 2 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 9 Jun 2021. 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?
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?
Whether death occurred during hospitalization after surgery (time frame: Within 30 days after discharge). 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 9 Jun 2021.