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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: Patients diagnosed with postoperative complications; Other: Patients without postoperative complications

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 Type: Observational
• Enrollment (Anticipated): 70000

Contacts and Locations

• Study Contact: Name: Yuefu Wang, MD; Email: wangyuefu@hotmail.com
• Study Contact Backup: Name: Yuchen Gao, MD; Email: gaoyuchen_pumc@hotmail.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
    • Contact: Yuefu Wang, MD; Phone Number: +(86) 010-88396509; Email: wangyuefu@hotmail.com
    • Contact: Chunrong Wang, MD; Phone Number: +(86) 010-88392469; Email: Emancipation258@outlook.com
    • Principal Investigator: Yuefu Wang, MD
    • Sub-Investigator: Chunrong Wang, MD
    • Sub-Investigator: Yuchen Gao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients who are going to have an cardiovascular operation.

Description

Inclusion Criteria:

Age more than 18 years Undergoing Cardiovascular surgery

Exclusion Criteria:

Missing primary outcomes or variables

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with postoperative complications	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	Other: Patients without postoperative complications; Patients without postoperative complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications: acute kidney injury	Diagnosed acute kidney injury (KDIGO)	30 dyas
postoperative complications: Chronic Kidney disease	Diagnosed Chronic Kidney disease	30 days, as follow up
postoperative complications: Infection	Diagnosed infection	30 days
postoperative complications: delirium	Diagnosed delirium (CAM,CAM-ICU)	30 days
postoperative complications: MACCE	Diagnosed MACCE	30 days, as follow up
postoperative complications: major bleeding	Diagnosed major bleeding	30 days
postoperative complications: postoperative pulmonary complications	Diagnosed postoperative pulmonary complications	30 days
postoperative complications: ECMO	patients with ECMO	30 days
postoperative complications: IABP	patients with IABP	30 days
Ventilation time	Number of hours the patient with mechanical ventilation	Through study completion, an average of 7 days
Length of ICU stay	Number of days the patient stays in the intensive care unit	Through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hospital costs	Total cost of the stay in the hospitalization (USD)	Through study completion, an average of 30 days
ICU costs	Total cost of the stay in the intensive care unit (USD)	Through study completion, an average of 30 days
Length of hospital stay	Number of days the patient stays in the hospital	Through study completion, an average of 30 days
Length of postoperative hospital stay	Number of days the patient stays in the hospital after surgery	Through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Yuefu Wang, MD, China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 12, 2025

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 9, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Prediction Model of CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No