Cardiac surgery with cardiopulmonary bypass Circulatory System
Conditions
Interventions
The researchers will see how accurately they can use measurements in the body (biomarkers) to predict organ injury. These biomarkers have been identified before in an ethically approved study (COPTIC
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) enrolled in the COPTIC trial (ISRCTN20778544) in Bristol UK for whom there are available samples and data
Exclusion criteria
Exclusion criteria: Participants of the COPTIC trial who did not provide consent for the use of samples and/or data for further ethically approved research (i.e., the present trial), and for whom there are insufficient samples and data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Derived from data and samples collected pre- and post-surgery: 1. Novel biomarkers identified in existing studies including: 1.1. Serum cytokines considered to be indicators of the severity of the inflammatory response to surgery, measured from serum on the Luminex MAGPIX Analyser (Oosterhout, NL) 1.2. Extracellular vesicles in plasma (EV) assessed by flow cytometry 1.3. Exosome and EV derived microRNA assessed by quantitative reverse transcription PCR (qRT-PCR) and next-generation sequencing 1.4. Targeted metabolomics for biomarkers of frailty, acute kidney injury acute lung injury, and coagulopathy, analysed using a targeted assay on a Thermo Qunativa interfaced with a Vanquish LC25 1.5. Other organ injury biomarkers; plasma proteins, coagulation assays, performed by next-generation sequencing and analysis of a panel of metabolites by mass spectrometry 2. Acute kidney injury (AKI) defined by clinical consensus criteria: RIFLE, AKIN, KDIGO, or by serial biomarker levels: serum creatinine, and soluble urokinase plasminogen activator receptor (uPAR) 3. Myocardial injury defined clinically as low cardiac output, which is new intra- or postoperative intra-aortic balloon pump insertion or a cardiac index of <2.2 l min-1 m-2 refractory to appropriate intravascular volume expansion after correction or attempted correction of any dysrhythmias, or the administration of ionotropes including dobutamine, enoximone, milrinone, levosimendan and adrenaline, or by serial biomarker levels: serum troponin 4. Acute lung injury (ALI) defined by clinical consensus criteria: ALI Score, Berlin ARDS Score, or by serial PaO2/FiO2 ratio 5. Coagulopathy defined using the COPTIC trial definition, or by point-of-care or laboratory tests of coagulopathy | — |
Secondary
| Measure | Time frame |
|---|---|
| Extracted from anonymised clinical trial data pre- and post-surgery: 1. Any red cell transfusion* 2. Red cell transfusion of =5 units* 3. Mortality 4. Myocardial infarction 5. Intra-aortic balloon pump 6. Stroke 7. Acute kidney injury (Yes/No) 8. Serum creatinine to estimate AKI grade 1, AKI grade 2, and AKI grade 3 on days 1-5 post surgery 9. Sepsis 10. Length of stay in ICU 11. Length of stay in hospital *reoperation of red cell transfusion for surgical causes of bleeding are excluded | — |
Countries
England, United Kingdom
Outcome results
None listed