Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

Phase 3TerminatedNCT01067703

University Hospital Schleswig-Holstein1,400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,400

Conditions

Myocardial Injury Mortality

Interventions

Remote Ischemic PreconditioningPROCEDURE

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.

Control/sham procedure (blood pressure cuff)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (10)

University Hospital Aachen (RWTH)

Aachen, Germany

University Hospital Charite

Berlin, Germany

University Hospital Bonn

Bonn, Germany

University Hospital Frankfurt/M

Frankfurt/M, Germany

Outcomes

Primary Outcomes

Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure

Time frame until hospital discharge

Time frame: In-hospital

Secondary Outcomes

Occurence of any component of the composite outcome

Time frame: Postoperative hospital discharge, 3 months, 12 months

length of stay on the intensive care unit

Time frame: Postoperative during hospital stay

total hospital stay

Time frame: hospital discharge

new onset of atrial fibrillation

Time frame: In-hospital

Delirium

Time frame: Postoperative 24, 48, 72, 96 hrs

Data from ClinicalTrials.gov

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