Clinical trial NCT01071265: Remote Ischemic Preconditioning in Cardiac Surgery Trial
Official title: Remote Ischemic Preconditioning in Cardiac Surgery: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2010-02-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Peak CK-MB within 24 hours after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Change in serum creatinine
timeFrame: within 4 days after surgery
measure: All-cause mortality
timeFrame: 6 months after surgery
measure: Need for Dialysis
timeFrame: 6 months after surgery
measure: Length of hospital stay
timeFrame: Discharge from hospital after surgery
measure: Length of stay in the intensive care unit
timeFrame: Discharge from hospital after surgery
measure: Incidence of pneumonia
timeFrame: 30 days after surgery
measure: Incidence of stroke
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Centre
state: Maine
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Halifax
country: Canada
facility: Maritime Heart Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Michael Walsh, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: PJ Devereaux, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.