Mortality, Myocardial Injury
Conditions
Keywords
remote ischaemic preconditioning, cardiac surgery
Brief summary
The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.
Detailed description
Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.
Interventions
PROCEDURERemote Ischemic Preconditioning
RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200 mm Hg, whereas the pressure has to be at least 20 mm Hg greater than the systolic arterial pressure measured via the arterial line.
PROCEDUREControl/sham procedure (blood pressure cuff)
Sham placement of the blood pressure cuff around a dummy arm inflated to a pressure of 200 mm Hg with four cycles of 5 min inflation and 5 min deflation.
Sponsors
German Research Foundation
Goethe University
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing heart surgery on cardiopulmonary bypass
Exclusion criteria
* age \< 18 * Emergency cases * left ventricular ejection fraction less than 30% * current atrial fibrillation * Inability to give informed consent * preoperative use of inotropics or mechanical assist device * severe liver, renal and pulmonary disease * recent myocardial infarction (within 7 days) * recent systemic infection or sepsis (within 7 days) * severe stroke (within 2 months) * peripheral vascular disease affecting upper limbs * previous serious psychiatric disorders (e.g. schizophrenia, dementia) * concomitant carotid endarterectomy * rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure | In-hospital | Time frame until hospital discharge |
Secondary
| Measure | Time frame |
|---|---|
| Occurence of any component of the composite outcome | Postoperative hospital discharge, 3 months, 12 months |
| length of stay on the intensive care unit | Postoperative during hospital stay |
| total hospital stay | hospital discharge |
| new onset of atrial fibrillation | In-hospital |
| Delirium | Postoperative 24, 48, 72, 96 hrs |
Countries
Germany
Outcome results
None listed