Plasma Biomarkers in Cardiac Valve Surgery

• Conditions: Elective Valvular Cardiac Surgery

• Registration Number: NCT02641665
• Lead Sponsor: University of Liege

Brief Summary

The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Study Start: 2016-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Age ≥ 18 years
• Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG

Exclusion Criteria

• Emergency or salvage surgery
• Inability to consent
• Previous cardiac surgery
• Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis
• Active Endocarditis
• Liver cirrhosis
• Chronic atrial fibrillation
• Pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome	30 days	In hospital or 30-days mortality or inotropic support during more than 48 hours or lengthy of ICU stay longer than 5 days

Secondary Outcome Measures

Name	Time	Method
one year mortality	1 year	mortality during the first postoperative year.
ICU readmission	30 days
NYHA	1 year	NYHA class at 30 days and at 1 year
Post-operative AKI	48 hours	AKIN stage during the first 48 hours
Ejection fraction	1 year	EF at 30 days and at 1 year
reshopitalisation	1 year	hospital admission for cardiac failure during the first postoperative year
MLHFQ	1 year	Minnesota living with heart failure questionnaire at 30 days and at 1 year

Trial Locations

Locations (1)

CHU of Liege; 🇧🇪 Liege, Belgium