Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Terminated; Phase 3

Conditions: Mortality; Myocardial Injury

Treatments: Procedure: Control/sham procedure (blood pressure cuff); Procedure: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01067703

ME 3559/1-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,400 participants in 2 patient groups

RIPC

Active Comparator group

Treatment:

Procedure: Remote Ischemic Preconditioning

CONTROL

Sham Comparator group

Treatment:

Procedure: Control/sham procedure (blood pressure cuff)