A Prediction Model for 1-year Mortality After Valvular Heart Surgery

Recruiting

• Conditions: Patients Undergoing Valvular Heart Surgery

• Registration Number: NCT05833256
• Lead Sponsor: Yonsei University

Brief Summary

The investigators aimed to develop a predictive model for mortality incorporating nutritional, inflammatory, and perioperative factors in patients undergoing valvular heart surgery. In this retrospective study, the investigators aimed to establish a comprehensive prediction model to predict the risk of 1-year mortality in valvular heart surgery patients through the identification of the inflammatory index most associated with 1-year mortality and developing a prognostic nomogram model incorporating perioperative risk factors with nutritional and inflammatory indices that would be verified by validation cohorts.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-02-28
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-27
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2046

Inclusion Criteria

1. patients who presented for surgery primarily due to valvular heart disease, including those who required concomitant coronary artery bypass surgery, aortic procedures, or other cardiac procedures.

Exclusion Criteria

1. patients aged <18 years
2. undergoing transcatheter valve replacement, combined congenital heart surgery, or implantation of ventricular assist device, 3) lacking data required for calculating inflammatory indices, or 4) follow-up loss.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year mortality after valvular heart surgery	1 year after valvular heart surgery	Mortality at follow-up was analysed using time-to-event analysis, with survival time defined as the time from date of surgery until date of death.

Secondary Outcome Measures

Name	Time	Method
neutrophil-to-lymphocyte ratio (NLR), calculated as the number of neutrophils divided by the number of lymphocytes	within 1 month before surgery	the white blood cell count with (neutrophil)
monocyte-to-lymphocyte ratio (MLR), calculated as the number of monocytes divided by the number of lymphocytes	within 1 month before surgery	the white blood cell count with ( monocyte)
platelet-to-lymphocyte ratio (PLR), calculated as the number of platelets divided by the number of lymphocytes	within 1 month before surgery	the white blood cell count with platelet

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of