Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery

Surgery--Complications Clinical Trial

— DV_model_CS  

Official title:

Development and Validation of Models to Predict Postoperative Complications for Patients With Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04884841
• Other study ID #: Prediction Model of CS
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 12, 2025

Study information

• Verified date: May 2021
• Source: China National Center for Cardiovascular Diseases
• Contact: Yuefu Wang, MD
• Email: wangyuefu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70000
• Est. completion date: December 12, 2025
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age more than 18 years Undergoing Cardiovascular surgery

Exclusion Criteria:

Missing primary outcomes or variables

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery--Complications

Intervention

Other:
• Patients diagnosed with postoperative complications
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 complications
Patients without postoperative complications

Locations

Country	Name	City	State
China	Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications: acute kidney injury	Diagnosed acute kidney injury (KDIGO)	30 dyas
Primary	postoperative complications: Chronic Kidney disease	Diagnosed Chronic Kidney disease	30 days, as follow up
Primary	postoperative complications: Infection	Diagnosed infection	30 days
Primary	postoperative complications: delirium	Diagnosed delirium (CAM,CAM-ICU)	30 days
Primary	postoperative complications: MACCE	Diagnosed MACCE	30 days, as follow up
Primary	postoperative complications: major bleeding	Diagnosed major bleeding	30 days
Primary	postoperative complications: postoperative pulmonary complications	Diagnosed postoperative pulmonary complications	30 days
Primary	postoperative complications: ECMO	patients with ECMO	30 days
Primary	postoperative complications: IABP	patients with IABP	30 days
Primary	Ventilation time	Number of hours the patient with mechanical ventilation	Through study completion, an average of 7 days
Primary	Length of ICU stay	Number of days the patient stays in the intensive care unit	Through study completion, an average of 30 days
Secondary	Total hospital costs	Total cost of the stay in the hospitalization (USD)	Through study completion, an average of 30 days
Secondary	ICU costs	Total cost of the stay in the intensive care unit (USD)	Through study completion, an average of 30 days
Secondary	Length of hospital stay	Number of days the patient stays in the hospital	Through study completion, an average of 30 days
Secondary	Length of postoperative hospital stay	Number of days the patient stays in the hospital after surgery	Through study completion, an average of 30 days