Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

Phase 3

Terminated

• Conditions: Myocardial Injury; Mortality
• Interventions: Procedure: Control/sham procedure (blood pressure cuff); Procedure: Remote Ischemic Preconditioning

• Registration Number: NCT01067703
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-11
• Study Start: 2010-12
• Primary Completion: 2014-05
• Status Verified: 2014-09
• Study Completion: 2015-05
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	Control/sham procedure (blood pressure cuff)	-
RIPC	Remote Ischemic Preconditioning	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Delirium	Postoperative 24, 48, 72, 96 hrs
total hospital stay	hospital discharge
length of stay on the intensive care unit	Postoperative during hospital stay
Occurence of any component of the composite outcome	Postoperative hospital discharge, 3 months, 12 months
new onset of atrial fibrillation	In-hospital

Trial Locations

Locations (10)

University Hospital Aachen (RWTH); 🇩🇪 Aachen, Germany

University Hospital Goettingen; 🇩🇪 Goettingen, Germany

University Hospital Charite; 🇩🇪 Berlin, Germany

University Hospital Bonn; 🇩🇪 Bonn, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany

University Hospital Magdeburg; 🇩🇪 Magdeburg, Germany

University Hospital Rostock; 🇩🇪 Rostock, Germany

University Hospital Frankfurt/M; 🇩🇪 Frankfurt/M, Germany

University Hospital of Schleswig-Holstein; 🇩🇪 Luebeck, Germany