C.Surgical Procedure; Cardiac
Conditions
Brief summary
This is a prospective, single-centre case control comparison of expression of target genes responsible for energy utilisation, mitochondrial function and oxidative stress and levels of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.
Interventions
None listed
Sponsors
University of Leicester
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation,
Exclusion criteria
* Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure. * Emergency or salvage procedure. * Ejection fraction \<30 %. * Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI \[20\] or requiring inotropes, ventilation or intra-aortic balloon pump). * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post surgery inotrope score | inotrope score measured up to 48 hours post-surgery | inotrope score measured up to 48 hours post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative clinical characteristics | Collected pre op | Perioperative clinical characteristics |
| Perioperative medications. | Collected pre op | Perioperative medications. |
| Changes in expression of target genes | Collected at the time of surgery | from right atrial biopsies |
| Changes in epigenetic regulation of target genes from left atrial biopsies. | Collected at the time of surgery | histone acetylation, DNA methylation |
| Acute kidney injury | baseline, and up to 15 days post surgery (discharge) | defined by serum creatinine level postoperatively, as per the KDIGO criteria |
| Myocardial Injury | baseline and 24 hours | defined by post cardiac surgery serum Troponin levels |
| Data to calculate Multiple Organ Dysfunction (MOD) score. | baseline, and up to 96 hours post surgery | To calculate the MOD score, the Respiratory Function (calculated as partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2)), Cardiovascular (Pressure adjusted heart rate (PAR) ), Renal (Serum Creatinine), Hepatic (serum bilirubi |
| Data to capture Acute Respiratory Distress Syndrome (Berlin criteria ARDS). | baseline, and up to 96 hours post surgery | Acute Lung Injury (ALI) non-ARDS, ARDS. To define these different categories of acute lung injury, the Positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) will be recorded in the CRF at time points: Pre-OP, ICU, 12 hrs post-op,24hrs post-op,48hrs post-op,72hrs post-op and 96hrs post-op. Along with the PaO2/FiO2 ratio, it will then be possible to categorise patients into the above definitions of acute lung injury as follows: ALI non-ARDS (200 mmHg \<PaO2/FiO2\<300 mmHg, regardless of PEEP),ARDS (PaO2/FiO2\<200 mmHg, regardless of PEEP), mild Berlin Definition(200mmHg \<PaO2/FiO2\<300mmHg with PEEP \> 5cm H2O),moderate Berlin Definition(100mmHg \<calculated as partial pressure of oxygen divided by fraction of inspired oxygen PaO2/FiO2 \< 200mmHg with PEEP \> 5cm H2O) and Severe Berlin Definition (PaO2/FiO2 \< 100mmHg with PEEP \> 5cm H2O) |
| Data on demographics | Pre Op | Height in cms |
| Changes in mitochondrial function | before and after sugery (up to 12 hours post surgery) | in atrial biopsies and buffy coats of blood samples collected before and after surgery |
Countries
United Kingdom
Contacts
Primary ContactTracy Kumar
Outcome results
None listed