Surgery--ComplicationsDV_model_CSNCT04884841
Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery
An observational study of Surgery--Complications, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified. A simple risk prediction model incorporating risk factors can help guide clinical decision making, patient counseling and treatment planning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Patients diagnosed with postoperative complications and Patients without postoperative complications
- How many people
- 70,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who are going to have an cardiovascular operation.
Who may be able to join
- Age more than 18 years Undergoing Cardiovascular surgery
Who cannot join
- Missing primary outcomes or variables
Trial locations and contacts
1 site in 1 country.
Yuefu Wang, MD contact
Yuchen Gao, MD contact
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
Beijing, 100037
Yuefu Wang, MD, +(86) 010-88396509, wangyuefu@hotmail.com
Chunrong Wang, MD, +(86) 010-88392469, Emancipation258@outlook.com
About this study
Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified. A simple risk prediction model incorporating risk factors can help guide clinical decision making, patient counseling and treatment planning.
Read the detailed description
Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified.A nomogram is a pictorial representation of a scoring model that possesses a simple user interface and shows favorable predictive performance. By integrating a patient's diverse determinant variables, a nomogram can provide a personalized probability for quantitative predictions of the incidence of an outcome of interest.Therefore, we conducted a retrospective study to assess the incidence, risk factors and outcomes associated with major complications patients undergoing cardiac surgery.
- Conditions
- Surgery--Complications
- Being tested
- Patients diagnosed with postoperative complications, Patients without postoperative complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients diagnosed with postoperative complicationsOther
Patients diagnosed with postoperative complications (Acute kidney injury, Chronic Kidney disease, Infection, Delirium, MACCE, Myocardial infarction, Postoperative pulmonary complications, major bleeding, ECMO, IABP....)
Patients without postoperative complicationsOther
Patients without postoperative complications
| Study group | Role | What they receive |
|---|---|---|
| Patients with postoperative complications | Patients with postoperative complications Receives: Other: Patients diagnosed with postoperative complications | |
| Patients without postoperative complications | Patients without postoperative complications Receives: Other: Patients without postoperative complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications: acute kidney injury
Diagnosed acute kidney injury (KDIGO)
Measured: 30 dyas
postoperative complications: Chronic Kidney disease
Diagnosed Chronic Kidney disease
Measured: 30 days, as follow up
postoperative complications: Infection
Diagnosed infection
Measured: 30 days
postoperative complications: delirium
Diagnosed delirium (CAM,CAM-ICU)
Measured: 30 days
postoperative complications: MACCE
Diagnosed MACCE
Measured: 30 days, as follow up
postoperative complications: major bleeding
Diagnosed major bleeding
Measured: 30 days
postoperative complications: postoperative pulmonary complications
Diagnosed postoperative pulmonary complications
Measured: 30 days
postoperative complications: ECMO
patients with ECMO
Measured: 30 days
postoperative complications: IABP
patients with IABP
Measured: 30 days
Ventilation time
Number of hours the patient with mechanical ventilation
Measured: Through study completion, an average of 7 days
Length of ICU stay
Number of days the patient stays in the intensive care unit
Measured: Through study completion, an average of 30 days
Secondary outcomes (4)
Total hospital costs
Total cost of the stay in the hospitalization (USD)
Measured: Through study completion, an average of 30 days
ICU costs
Total cost of the stay in the intensive care unit (USD)
Measured: Through study completion, an average of 30 days
Length of hospital stay
Number of days the patient stays in the hospital
Measured: Through study completion, an average of 30 days
Length of postoperative hospital stay
Number of days the patient stays in the hospital after surgery
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2021 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Other
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yuefu Wang, China National Center for Cardiovascular Diseases
- Investigators
- Yuefu Wang, MD, Principal investigator, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884841
- Sponsor's protocol ID
- Prediction Model of CS
- Acronym
- DV_model_CS
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04884841
- Acronym / sponsor ID
- DV_model_CS / Prediction Model of CS
- Conditions
- Surgery--Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 13 May 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.
Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified. A simple risk prediction model incorporating risk factors can help guide clinical decision making, patient counseling and treatment planning.
Detailed description
Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified.A nomogram is a pictorial representation of a scoring model that possesses a simple user interface and shows favorable predictive performance. By integrating a patient's diverse determinant variables, a nomogram can provide a personalized probability for quantitative predictions of the incidence of an outcome of interest.Therefore, we conducted a retrospective study to assess the incidence, risk factors and outcomes associated with major complications patients undergoing cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with postoperative complications | – | Other: Patients diagnosed with postoperative complicationsPatients with postoperative complications |
| Patients without postoperative complications | – | Other: Patients without postoperative complicationsPatients without postoperative complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who are going to have an cardiovascular operation.
Key inclusion criteria (1 listed)
- Age more than 18 years Undergoing Cardiovascular surgery
Key exclusion criteria (1 listed)
- Missing primary outcomes or variables
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 |
|---|---|---|
| Patients diagnosed with postoperative complicationsPatients diagnosed with postoperative complications (Acute kidney injury, Chronic Kidney disease, Infection, Delirium, MACCE, Myocardial infarction, Postoperative pulmonary complications, major bleeding, ECMO, IABP....) | Other | Patients with postoperative complications |
| Patients without postoperative complicationsPatients without postoperative complications | Other | Patients without postoperative complications |
Primary outcome
postoperative complications: acute kidney injury
Time frame: 30 dyas
Diagnosed acute kidney injury (KDIGO)
postoperative complications: Chronic Kidney disease
Time frame: 30 days, as follow up
Diagnosed Chronic Kidney disease
postoperative complications: Infection
Time frame: 30 days
Diagnosed infection
postoperative complications: delirium
Time frame: 30 days
Diagnosed delirium (CAM,CAM-ICU)
postoperative complications: MACCE
Time frame: 30 days, as follow up
Diagnosed MACCE
postoperative complications: major bleeding
Time frame: 30 days
Diagnosed major bleeding
postoperative complications: postoperative pulmonary complications
Time frame: 30 days
Diagnosed postoperative pulmonary complications
postoperative complications: ECMO
Time frame: 30 days
patients with ECMO
postoperative complications: IABP
Time frame: 30 days
patients with IABP
Ventilation time
Time frame: Through study completion, an average of 7 days
Number of hours the patient with mechanical ventilation
Length of ICU stay
Time frame: Through study completion, an average of 30 days
Number of days the patient stays in the intensive care unit
4 secondary outcomes
Total hospital costs
Time frame: Through study completion, an average of 30 days
ICU costs
Time frame: Through study completion, an average of 30 days
Length of hospital stay
Time frame: Through study completion, an average of 30 days
Length of postoperative hospital stay
Time frame: Through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- 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.
Yuefu Wang, MD contact
Yuchen Gao, MD contact
Yuefu Wang, MD principal investigator
China National Center for Cardiovascular Diseases
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 Surgery--Complications, run by China National Center for Cardiovascular Diseases 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 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 14 May 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?
Contact Yuefu Wang, MD (wangyuefu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications: acute kidney injury (time frame: 30 dyas). The study lists 11 primary outcomes in all. 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 14 May 2021.