Copeptin and HFABP in Cardiac Surgery

• Conditions: Valvular Heart Disease; Coronary Artery Disease
• Interventions: Diagnostic Test: Blood sampling

• Registration Number: NCT04877795
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, \>90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.

Detailed Description

The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.

All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Adult (≥ 18 years of age)
• Elective surgery
• On-pump cardiac surgery (CABG and/or valvular surgery)

Exclusion Criteria

• Heart transplantation (HTX)
• ACS at presentation (< 14 days)
• Emergency surgery
• Preoperative inotropic or mechanical circulatory support
• Left or right ventricular assist device implantation
• Unwilling or unable to provide consent
• Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Surgery	Blood sampling	Adult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery)

Primary Outcome Measures

Name	Time	Method
Disability-free survival	1 years after surgery	Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guidelines.

Secondary Outcome Measures

Name	Time	Method
Days alive and out of hospital	At 30 days and 12 months after surgery	Patient-centered outcome to measure morbidity and mortality after surgery
Major adverse cardiovascular events (MACE)	At 30 days and 12 months after surgery	Defined as non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure or transfer to a higher unit of care, atrial fibrillation or stroke
All cause mortality	At 30 days and 12 months after surgery	Evaluate mortality after cardiac surgery
Length of ICU-stay	At 30 days	To observe the length and/or readmission rate of intensive care unit stay
Acute kidney injury (AKI)	At 30 days	As defined by the three-stage KDIGO (Kidney Disease: Improving Global Outcome) classification of severity

Trial Locations

Locations (1)

Heinrich-Heine-Universität; 🇩🇪 Düsseldorf, NRW, Germany