Perioperative Troponin I and NT Pro-BNP in Lung Resection

Completed

• Conditions: Complication,Postoperative; Cardiac Ischemia; Thoracic Cancer

• Registration Number: NCT04749212
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

After lung resection, troponin elevation may be regulated by mechanisms other than myocardial ischemia. Perioperative natriuretic peptides measurement may help identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection.

Detailed Description

Objectives: To evaluate the incidence and magnitude of perioperative N-terminal pro brain natriuretic peptide (NT-proBNP) and high-sensitivity troponin I (Tn I) elevation in patients undergoing pulmonary resection and its predictive value for cardiovascular complications. Methodology: Prospective, multicenter, observational cohort study in patients \>45 years undergoing elective thoracic surgery for lung resection. Cardiac biomarkers Tn I and NT-proBNP will be measured preoperatively and at postoperative days 1 and 2. Risk score for major cardiovascular postoperative complications will be calculated depending of both biomarkers perioperative changes.

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-11
• Study Start: 2021-05-19
• Primary Completion: 2023-11-30
• Study Completion: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

• Age ≥45 years old
• Patients undergoing elective surgery for lung resection

Exclusion Criteria

• Patients undergoing urgent, emergent, or nonthoracic surgery
• Patients or family did not consent to participate
• Presence of symptoms related with infection or sepsis
• Patients with a documented history of severe heart failure and/or ejection fraction lower than 30%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NT-proBNP perioperative changes	Change from baseline NT-proBNP at two-days after surgery	Perioperative change in NT-Pro-Brain Natriuretic Peptide (NT-proBNP) levels in patients undergoing pulmonary resection. Cutt-of values will be NT-proBNP ≥ 300 pg/ml pg/ml
TnI perioperative changes	Change from baseline TnI at two-days after surgery	Perioperative changes in high-sensitivity troponin I (TnI) levels in patients undergoing pulmonary resection. Cutt-of values will be TnI ≥45 ng/L
Major cardiovascular complications	30-days after surgery	Postoperative non-fatal cardiac arrest, acute myocardial infarction, angina, congestive heart failure, new clinically relevant cardiac arrhythmia, cardiovascular death

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain