Clinical trial NCT04877795: Copeptin and HFABP in Cardiac Surgery
Official title: Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Valvular Heart Disease
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective on-pump cardiac surgery (i.e. CABG and/or valvular surgery).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability-free survival
timeFrame: 1 years after surgery
Secondary outcomes:
measure: Days alive and out of hospital
timeFrame: At 30 days and 12 months after surgery
measure: Major adverse cardiovascular events (MACE)
timeFrame: At 30 days and 12 months after surgery
measure: All cause mortality
timeFrame: At 30 days and 12 months after surgery
measure: Length of ICU-stay
timeFrame: At 30 days
measure: Acute kidney injury (AKI)
timeFrame: At 30 days
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität
state: NRW
Study officials:
References: