Remote Ischaemic Preconditioning for Heart Surgery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Myocardial Injury
- Sponsor
- University Hospital Schleswig-Holstein
- Enrollment
- 1400
- Locations
- 10
- Primary Endpoint
- Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Patrick Meybohm
Prof. Dr. Patrick Meybohm
University Hospital Schleswig-Holstein
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure
Time Frame: In-hospital
Time frame until hospital discharge
Secondary Outcomes
- length of stay on the intensive care unit(Postoperative during hospital stay)
- total hospital stay(hospital discharge)
- Occurence of any component of the composite outcome(Postoperative hospital discharge, 3 months, 12 months)
- new onset of atrial fibrillation(In-hospital)
- Delirium(Postoperative 24, 48, 72, 96 hrs)