Postoperative DeathNCT04926012
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery
An observational study of Postoperative Death, run by Huazhong University of Science and Technology at 5 sites in China.
Trial summary
The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Death
- How many people
- 100,000 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jul 2021to 31 Dec 2022
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients Undergoing Cardiovascular Surgery
Who may be able to join
- Patients Undergoing Cardiovascular Surgery
Who cannot join
- Patients with incomplete electronic medical record information
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
Beijing, Beijing Municipality, 100050
Xiangya Hospital, Hunan, China
Changsha, Hunan, 410008
Shanxi Bethune hospital, Shanxi, China
Taiyuan, Shanxi, 030032
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Henan People's Hospital, Henan, China
Zhengzhou, Henan, 450003
About this study
The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery.
The investigators identify all patients treated with cardiovascular surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.
60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.
- Conditions
- Postoperative Death
- Keywords
- Postoperative death, Cardiovascular surgery, Prediction model
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Death
Measured: The mortality within 5 years after the cardiovascular surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start30 Jul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeathStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC, Henan Provincial People's Hospital, Xiangya Hospital, Shanxi Bethune Hospital
- Responsible party
- Principal investigator, Shanglong Yao, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926012
- Sponsor's protocol ID
- PODSV1
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT04926012
- Acronym / sponsor ID
- PODSV1
- Conditions
- Postoperative Death
- Keywords
- Postoperative death, Cardiovascular surgery, Prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC, Henan Provincial People's Hospital, Xiangya Hospital, Shanxi Bethune Hospital
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 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 are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery.
The investigators identify all patients treated with cardiovascular surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.
60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Undergoing Cardiovascular Surgery
Key inclusion criteria (1 listed)
- Patients Undergoing Cardiovascular Surgery
Key exclusion criteria (1 listed)
- Patients with incomplete electronic medical record information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Death
Time frame: The mortality within 5 years after the cardiovascular surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Death, run by Huazhong University of Science and Technology at 5 sites 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 1 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 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Yu Wang, Dr. (+86 15972918891, wangdayuanesthe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Death (time frame: The mortality within 5 years after the cardiovascular surgery). 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 26 Jul 2021.