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

Recruiting

• Conditions: Surgery--Complications
• Interventions: Other: Patients diagnosed with postoperative complications; Other: Patients without postoperative complications

• Registration Number: NCT04884841
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

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 Timeline

• Study Start: 2012-01-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-14
• Primary Completion: 2021-12-31
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70000

Inclusion Criteria

Age more than 18 years Undergoing Cardiovascular surgery

Exclusion Criteria

Missing primary outcomes or variables

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with postoperative complications	Patients diagnosed with postoperative complications	Patients with postoperative complications
Patients without postoperative complications	Patients without postoperative complications	Patients without postoperative complications

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC; 🇨🇳 Beijing, China