[last updated 15/05/2012]
253 Patients Recruited
Effect of Remote Ischaemic preConditioning on clinical outcomes in patients undergoing Coronary Artery Bypass Graft surgery (ERICCA): A multicentre randomised controlled clinical trial.
Purpose of the trial:
To determine whether remote ischaemic preconditioning (RIC) improves clinical outcomes after cardiac surgery.
Primary objective:
To determine the effect of RIC on Major Adverse Cardiac and Cerebral Events (MACCE) 12 months after cardiac surgery. MACCE include cardiovascular (CV) death, myocardial infarction, revascularisation, and stroke.
Secondary objectives:
To determine the effects of RIC on:
- 30 day MACCE
- All cause death
- Peri-operative myocardial injury (Troponin T in the first 72 hours post-surgery)
- Peri-operative renal injury (creatinine and 24 hours serum Neutrophil Gelatinase Associated Lipocalin (NGAL)) post-surgery
- Length of Intensive Therapy Unit (ITU) stay
- Inotrope score
- Hospital stay
- 6 minute walk test
- Quality of life
- Echo Substudy: Left ventricular ejection fraction
Patient Eligibility:
Inclusion criteria
- Patients undergoing CABG with or without valve surgery using blood cardioplegia
- Patients aged 18 years and above
- Patients with an additive Euroscore greater than or equal to 5
Exclusion criteria
- Cardiogenic shock*
- Cardiac arrest on current admission
- Pregnancy
- Significant peripheral arterial disease affecting the upper limbs
- Patients with significant hepatic dysfunction (INR>2)
- Patients with significant pulmonary disease (FEV1<40% predicted)
- Patients with known renal failure with a GFR<30 mL/min/1.73 m2
- Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
- Patients recruited into another study which may impact on the ERICCA study
*Definition of cardiogenic shock:
Systolic blood pressure <90 mm Hg for 30 minutes before inotrope/vasopressor administration
OR
Vasopressors or IABP are required to maintain systolic blood pressure >90 mm Hg