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Remote Ischemic Preconditioning in Cardiac Surgery Trial

2014-07-23 21:10:24 | BioPortfolio

Summary

Main Research Questions:

1. Does temporarily stopping bloodflow to a limb (a procedure called remote ischemic preconditioning) before heart surgery help protect the heart and kidneys and if so,

2. What regimen (i.e. how many times and in which limb) provides the best protection?

What is Being Studied:

A simple procedure known as remote ischemic preconditioning. The procedure is performed by inflating a pressurized cuff around either the arm and/or 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 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 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 impact 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). Before performing a large trial that determines whether RIPC improves patient-important outcomes, the optimal regimen of RIPC must be identified. We will determine the effect of RIPC on heart and kidney injury and determine what regimen of RIPC is most effective in our pilot randomized control trial. This trial will enroll 700 patients in 6 different RIPC regimens and compare them to a group that receives only a sham procedure (i.e. no real RIPC). We call this trial the Remote IscheMia Preconditioning in cArdiaC surgery Trial (Remote IMPACT).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Cardiac Surgery

Intervention

Remote Ischemic Preconditioning, Sham

Location

McMaster University
Hamilton
Ontario
Canada

Status

Not yet recruiting

Source

McMaster University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:24-0400

Clinical Trials [2399 Associated Clinical Trials listed on BioPortfolio]

Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery

Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (...

Remote Ischemic Preconditioning After Cardiac Surgery

Acute kidney injury (AKI) is a well-recognized complication after cardiac surgery with cardiopulmonary bypass (CPB). The aim of this study is to reduce the incidence of AKI by implementing...

Ischaemic PReconditioning In Non Cardiac surgEry

Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery. Remote ischemic ...

Effect of Propofol on Cardioprotective Role of RIPC

This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning cardioprotective outcomes. Remote ischemic precondit...

PubMed Articles [15318 Associated PubMed Articles listed on BioPortfolio]

Remote Ischemic Preconditioning does not Prevent White Matter Injury in Neonates.

Remote ischemic preconditioning (RIPC) is a mechanism to protect tissues from injury during ischemia and reperfusion. We investigated the neuroprotective effects of RIPC in neonates undergoing cardiac...

Mirna-Mediated Mechanisms of Cardiac Protection in Ischemic and Remote Ischemic Preconditioning - A Qualitative Systematic Review.

Ischemic preconditioning (IPC) and remote ischemic preconditioning (RIPC) protect myocardial tissue against subsequent ischemia and reperfusion injury (IRI) and have a high potential to improve patien...

Remote Ischemic Preconditioning in High-risk Cardiovascular Surgery Patients: A Randomized-controlled Trial.

Remote ischemic preconditioning (RIPC) may reduce biomarkers of ischemic injury after cardiovascular surgery. However, it is unclear whether RIPC has a positive impact on clinical outcomes. We perform...

Remote Ischemic Preconditioning Does Not Affect the Release of Humoral Factors in Propofol-Anesthetized Cardiac Surgery Patients: A Secondary Analysis of the RIPHeart Study.

In contrast to several smaller studies, which demonstrate that remote ischemic preconditioning (RIPC) reduces myocardial injury in patients that undergo cardiovascular surgery, the RIPHeart study fail...

Protecting the heart from ischemia/reperfusion injury: an update on remote ischemic preconditioning and postconditioning.

The most effective strategy for reducing acute myocardial ischemic injury is timely and effective reperfusion. However, myocardial reperfusion can induce further cardiomyocyte death (reperfusion injur...

Medical and Biotech [MESH] Definitions

The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.

A technique in which tissue is rendered resistant to the deleterious effects of prolonged ischemia and reperfusion by prior exposure to brief, repeated periods of vascular occlusion. (Am J Physiol 1995 May;268(5 Pt 2):H2063-7, Abstract)

Procedures that avoid use of open invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device. With the reduced trauma associated with minimally invasive surgery, long hospital stays may be reduced with increased rates of short stay or day surgery.

Consultation via remote telecommunications, generally for the purpose of diagnosis or treatment of a patient at a site remote from the patient or primary physician.

Procedures that avoid use of open, invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-controlled manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device.

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