Remote Ischemic Preconditioning in Cardiac Surgery Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Cardiac Surgery

In brief

Main Research Questions: 1. Is a large trial of patients undergoing heart surgery comparing a simple procedure of temporarily stopping blood flow to the leg with a blood pressure cuff (called remote ischemic preconditioning) to a sham procedure possible? 2. Does the remote ischemic preconditioning procedure before heart surgery help protect the heart and kidneys? What is Being Studied: A simple procedure known as remote ischemic preconditioning. The procedure is performed by inflating a pressurized cuff the thigh to temporarily stop blood flow to the arm or leg. This procedure causes the body to have a stress response that, at the cellular level, may protect major organs like the heart and kidney from the damage caused to them by the much larger stress of cardiac surgery. Reducing this damage may improve patient's recovery after surgery and help them live longer. Why is this study important?: This research is important because up to 1 in every 20 patients that undergo heart surgery die before even leaving hospital. Preventing heart and kidney damage at the time of surgery with remote ischemic preconditioning may reduce patient deaths.

Key facts

Study ID

NCT01071265

Run by

McMaster University

People needed

250

Starts

2011-03-01

Expected to finish

2013-01-01

Last updated by the study team

2015-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• undergoing cardiac surgery
• at least 18 years old
• EuroSCORE >= 6

You may not qualify if…

• requiring intra-aortic balloon pump support prior to surgery
• unable to provide informed consent or decline to participate

Where it is running

• Maine Medical Centre — Portland, Maine, United States
• Wake Forest — Winston-Salem, North Carolina, United States
• University of Calgary — Calgary, Alberta, Canada
• Maritime Heart Centre — Halifax, Nova Scotia, Canada
• McMaster University — Hamilton, Ontario, Canada
• Lawson Health Research Institute — London, Ontario, Canada
• Sunnybrook Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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