Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

Study 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.

Official Title
-----------------
Remote Ischaemic Preconditioning for Heart Surgery

Conditions
-----------------
Mortality, Myocardial Injury

Intervention / Treatment
-----------------
* Procedure: Remote Ischemic Preconditioning
* Procedure: Control/sham procedure (blood pressure cuff)


Participation Criteria
=================
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) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC<br> | Procedure: Remote Ischemic Preconditioning<br>* 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.<br>|
| Sham Comparator: CONTROL<br> | Procedure: Control/sham procedure (blood pressure cuff)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure | Time frame until hospital discharge | In-hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote ischaemic preconditioning, cardiac surgery