Remote Ischemic Preconditioning in Cardiac Surgery Trial (Remote IMPACT)
|ClinicalTrials.gov Identifier: NCT01071265|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : September 28, 2015
Main Research Questions:
- 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?
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery||Procedure: Remote Ischemic Preconditioning Procedure: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Remote Ischemic Preconditioning in Cardiac Surgery: a Pilot Randomized Controlled Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||January 2013|
Placebo Comparator: Sham RIPC
Inflation of thigh pneumatic tourniquet to <15 mmHg
Sham procedure. A pneumatic tourniquet is placed on an upper arm and/or thigh but not inflated.
Active Comparator: Active RIPC
300 mmHg inflation of thigh pneumatic tourniquet for three cycles of 5 minutes each with 5 minutes of no inflation between cycles.
Procedure: 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.
- Peak CK-MB within 24 hours after surgery [ Time Frame: 24 hours ]Peak CK-MB within 24 hours after surgery
- Change in serum creatinine [ Time Frame: within 4 days after surgery ]
- All-cause mortality [ Time Frame: 6 months after surgery ]
- Need for Dialysis [ Time Frame: 6 months after surgery ]
- Length of hospital stay [ Time Frame: Discharge from hospital after surgery ]
- Length of stay in the intensive care unit [ Time Frame: Discharge from hospital after surgery ]
- Incidence of pneumonia [ Time Frame: 30 days after surgery ]
- Incidence of stroke [ Time Frame: 6 months after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071265
|United States, Maine|
|Maine Medical Centre|
|Portland, Maine, United States|
|United States, North Carolina|
|Winston-Salem, North Carolina, United States|
|University of Calgary|
|Calgary, Alberta, Canada|
|Canada, Nova Scotia|
|Maritime Heart Centre|
|Halifax, Nova Scotia, Canada|
|Hamilton, Ontario, Canada|
|Lawson Health Research Institute|
|London, Ontario, Canada|
|Toronto, Ontario, Canada|
|Principal Investigator:||Michael Walsh, MD MSc||McMaster University|
|Principal Investigator:||PJ Devereaux, MD PhD||McMaster University|