Remote Ischemic Preconditioning in Cardiac Surgery Trial

Cardiac Surgery Clinical Trial

— Remote IMPACT  

Official title:

Remote Ischemic Preconditioning in Cardiac Surgery: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071265
• Other study ID #: 09-536
• Secondary ID: NIF-09223CANNeCT
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: September 24, 2015
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
Canada	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
United States	Maine Medical Centre	Portland	Maine
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak CK-MB within 24 hours after surgery	Peak CK-MB within 24 hours after surgery	24 hours	No
Secondary	Change in serum creatinine		within 4 days after surgery	No
Secondary	All-cause mortality		6 months after surgery	Yes
Secondary	Need for Dialysis		6 months after surgery	No
Secondary	Length of hospital stay		Discharge from hospital after surgery	No
Secondary	Length of stay in the intensive care unit		Discharge from hospital after surgery	No
Secondary	Incidence of pneumonia		30 days after surgery	No
Secondary	Incidence of stroke		6 months after surgery	No