Remote Ischemic Preconditioning in Cardiac Surgery Trial

NCT ID: NCT01071265

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

Detailed Description

Annually, 2 million patients worldwide undergo heart surgery. Although this procedure can prolong life, 1 in 20 patients will not survive their hospital stay. Acute heart and kidney injuries are important causes of death after heart surgery. Remote ischemic preconditioning (RIPC) is a promising and simple therapy that may simultaneously reduce heart and kidney damage. RIPC involves the inflation of a tourniquet or blood pressure cuff on a limb to briefly stop blood flow to that limb. This period of no blood flow activates the body's own protective systems and releases protective chemicals into the blood that also protect the heart and kidneys. RIPC is a particularly attractive potential treatment because it may protect several organs at once, it has no known adverse effects and costs almost nothing. RIPC could therefore very easily be used globally to improve outcomes for all patients undergoing heart surgery. Although RIPC appears very promising in several small studies using different RIPC regimens there are no studies large enough to definitively evaluate whether RIPC improves patient important outcomes (e.g. survival, kidney failure, major heart attack, or stroke). Before performing a large trial to determine whether RIPC is effective, we must demonstrate that such a trial is feasible. We will determine the recruitment rate and adequacy of follow-up in an international group of centres to ensure that an adequately powered trial of RIPC compared to a sham procedure is possible. Further, we will ensure that our RIPC regimen is consistent with other trials in terms of effects on cardiac and kidney injury. This pilot trial will enroll 250 patients and randomize half to RIPC and half to a sham procedure. We call this trial the Remote IscheMia Preconditioning in cArdiaC surgery Trial (Remote IMPACT).

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham RIPC

Inflation of thigh pneumatic tourniquet to \<15 mmHg

Group Type: PLACEBO_COMPARATOR

Sham

Intervention Type: PROCEDURE

Sham procedure. A pneumatic tourniquet is placed on an upper arm and/or thigh but not inflated.

Active RIPC

300 mmHg inflation of thigh pneumatic tourniquet for three cycles of 5 minutes each with 5 minutes of no inflation between cycles.

Group Type: ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type: PROCEDURE

Occlusion of leg blood flow using a pneumatic tourniquet on the thigh. Tourniquets are inflated to 300 mmHg for 5 minutes followed by deflation for 5 minutes then repeated for a total of 3 inflations.

Interventions

Remote Ischemic Preconditioning

Occlusion of leg blood flow using a pneumatic tourniquet on the thigh. Tourniquets are inflated to 300 mmHg for 5 minutes followed by deflation for 5 minutes then repeated for a total of 3 inflations.

Intervention Type: PROCEDURE

Sham

Sham procedure. A pneumatic tourniquet is placed on an upper arm and/or thigh but not inflated.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Walsh, MD MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

PJ Devereaux, MD PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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

Countries

United States; Canada

References

Walsh M, Whitlock R, Garg AX, Legare JF, Duncan AE, Zimmerman R, Miller S, Fremes S, Kieser T, Karthikeyan G, Chan M, Ho A, Nasr V, Vincent J, Ali I, Lavi R, Sessler DI, Kramer R, Gardner J, Syed S, VanHelder T, Guyatt G, Rao-Melacini P, Thabane L, Devereaux PJ; Remote IMPACT Investigators. Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial. CMAJ. 2016 Mar 15;188(5):329-336. doi: 10.1503/cmaj.150632. Epub 2015 Dec 14.

Reference Type: DERIVED

PMID: 26668200 (View on PubMed)

Other Identifiers

NIF-09223

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CANNeCTIN Funding

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

09-536

Identifier Type: -

Identifier Source: org_study_id