Copeptin and HFABP in Cardiac Surgery
PRACTICE
Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study
1 other identifier
observational
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMay 7, 2021
May 1, 2021
2 years
May 3, 2021
May 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Disability-free survival
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.
1 years after surgery
Secondary Outcomes (5)
Days alive and out of hospital
At 30 days and 12 months after surgery
Major adverse cardiovascular events (MACE)
At 30 days and 12 months after surgery
All cause mortality
At 30 days and 12 months after surgery
Length of ICU-stay
At 30 days
Acute kidney injury (AKI)
At 30 days
Study Arms (1)
Cardiac Surgery
Adult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery)
Interventions
Blood will be sampled from enrolled patients and analyzed for levels of troponin, copeptin and heart-type fatty acid binding protein (HFABP).
Eligibility Criteria
Adult patients undergoing elective on-pump cardiac surgery (i.e. CABG and/or valvular surgery).
You may qualify if:
- Adult (≥ 18 years of age)
- Elective surgery
- On-pump cardiac surgery (CABG and/or valvular surgery)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heinrich-Heine-Universität
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (1)
Kirkopoulos A, Salehi I, M'Pembele R, Maddison P, Stroda A, Tenge T, Donaldson D, Huhn R, Kindgen-Milles D, Haddad A, Brands J, Dubler S, Brenner T, Berger MM, Lurati Buse G, Roth S. Predictive value of early postoperative copeptin after cardiac surgery: A two-centre prospective cohort study. Eur J Anaesthesiol. 2025 Nov 1;42(11):1017-1024. doi: 10.1097/EJA.0000000000002251. Epub 2025 Aug 1.
PMID: 40755220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 7, 2021
Study Start
April 1, 2021
Primary Completion
March 31, 2023
Study Completion
June 30, 2023
Last Updated
May 7, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
Data will be entered into a secure on-line database documenting the time and individual entering the data. Data will be collected directly from source documents into the eCRF. A copy of the original source documents will be stored within a locked cabinet/office accessible to authorized personnel only. An identifiable patient data page reporting the assigned patient identification code will be stored separately also in a locked cabinet/office (accessible to authorized personnel only) in order to record in-hospital outcomes, conduct follow-up, supply missing data points, and to allow potential monitoring visits by regulatory authorities. All collected data will be archived for a period of 15 years. The secure database run by the clinical trials unit of the University Hospital Duesseldorf allows for data entry accountability and high security standards.