Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

NCT04265807 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00005176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.

Conditions

Cardiac Arrest

Keywords

reperfusion injury; remote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• Attrition

  Attrition assessed as the proportion of randomized subjects who do not remain on allocated therapy for the intended study duration among subjects randomly allocated. On therapy for the intended study duration consists of completing three cycles of inflation-deflation.

  Completion of their allocated study intervention, an average of 30 minutes from enrollment

Secondary Outcomes (13)

• Treatment Success

  30 minutes from initiation of study intervention

• Cardiac Function

  Within 48 hours of index arrest

• Proportion With Cardiogenic Shock, %

  Within 48 hours of index arrest

• STEMI

  Within 48 hours of index arrest

• Myocardial Injury

  Within 24 hours of index arrest

Other Outcomes (6)

• Device Failure

  30 minutes from initiation of study intervention

• Expected Adverse Event Related to Device- Pain

  Within 24 hours of Enrollment

• Expected Adverse Event Related to Device- Thrombophlebitis

  Within 1 week of Enrollment

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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.

Device: Active Remote Ischemic Conditioning

Control Group

SHAM COMPARATOR

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.

Device: Sham Remote Ischemic Conditioning

Interventions

Active Remote Ischemic Conditioning DEVICE

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 a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods.

Intervention Group

Sham Remote Ischemic Conditioning DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Included will be those with: 1. Age 18 years or more; 2. Defibrillation by laypersons or defibrillation and/or chest compressions by EMS providers dispatched to the scene; 3. Non-traumatic etiology of arrest, defined as without concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination; 4. Spontaneous circulation upon emergency department arrival; 5. No response to verbal commands; and 6. Ongoing or planned induced hypothermia. Excluded will be those with: 1. STEMI indicated on first 12-lead ECG obtained after restoration of circulation, defined as ST-elevation of ≥2 mm in two or more contiguous ECG leads; 2. Written do not attempt resuscitation (DNAR) reported to providers before randomization; 3. Drowning or hypothermia as cause of arrest; 4. Known prisoner or pregnant; or 5. Dialysis fistula in either upper extremity; or 6. Pre-existing amputation of upper extremity.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead
• Charles F. Kettering Foundation: collaborator

Study Sites (1)

Graham Nichol

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Heart Arrest; Reperfusion Injury

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a single-center pilot study. The rate of incomplete application of the intervention may be higher in a multi-center study. It lacked power to detect significant differences in outcomes, and did not include immunologic markers or markers of cardiac or brain injury. It assessed feasibility of the intervention rather than to assess whether RIC achieved a significant difference in biomarkers or clinical outcomes.

Results Point of Contact

• Title: Graham Nichol
• Organization: University of Washington

nichol@uw.edu

206 521 1784

Study Officials

• Graham Nichol, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Emilby S Bartlett, MD MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and investigators will be masked to treatment assignment up to the point of randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Department of Medicine: General Internal Medicine

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 12, 2020
• Study Start: July 1, 2020
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

US (1)