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Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

Phase 1

Recruiting

Led By Graham Nichol, MD, MPH

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours of enrollment

Summary

This trial is testing whether a technique called remote ischemic conditioning (RIC) can help improve outcomes for people who have had a cardiac arrest. RIC involves applying a device to a limb to intermittently restrict blood flow and induce non-lethal ischemia.

Eligible Conditions

Heart Attack

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours of index arrest

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours of index arrest

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours of index arrest for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attrition

Secondary study objectives

Accrual

Cardiac Function

Cardiogenic Shock

+10 more

Other study objectives

Device Failure

Expected Adverse Event Related to Cardiac Arrest

Expected Adverse Event Related to Device- Pain

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention GroupActive Control1 Intervention

A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods.

Group II: Control GroupPlacebo Group1 Intervention

The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group.

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