Clinical trial NCT04265807: Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot
Official title: Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: reperfusion injury
remote ischemic conditioning
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Charles F. Kettering Foundation
First posted: 2020-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Attrition
timeFrame: Completion of their allocated study intervention, an average of 30 minutes from enrollment
Secondary outcomes:
measure: Treatment Success
timeFrame: 30 minutes from initiation of study intervention
measure: Cardiac Function
timeFrame: Within 48 hours of index arrest
measure: Proportion With Cardiogenic Shock, %
timeFrame: Within 48 hours of index arrest
measure: STEMI
timeFrame: Within 48 hours of index arrest
measure: Myocardial Injury
timeFrame: Within 24 hours of index arrest
measure: Renal Dysfunction
timeFrame: Within 24 hours of index arrest
measure: Hospital Free Survival
timeFrame: Within 30 days of index arrest
measure: Withdrawal of Care
timeFrame: Discharge or 30 days after index arrest
measure: Favourable Neurologic Status at Discharge
timeFrame: Discharge or 30 days after index arrest
measure: Survival to Discharge
timeFrame: Discharge or 30 days after index arrest
measure: Clinical Instability at Discharge
timeFrame: Discharge or 30 days after index arrest
measure: Survival to 30 Days After Arrest
timeFrame: 30 days after index arrest
measure: Accrual
timeFrame: Before leaving the emergency department
Other outcomes:
measure: Device Failure
timeFrame: 30 minutes from initiation of study intervention
measure: Expected Adverse Event Related to Device- Pain
timeFrame: Within 24 hours of Enrollment
measure: Expected Adverse Event Related to Device- Thrombophlebitis
timeFrame: Within 1 week of Enrollment
measure: Expected Adverse Event Related to Device- Sepsis
timeFrame: Within 1 week of Enrollment
measure: Expected Adverse Event Related to Cardiac Arrest
timeFrame: Discharge or 30 days after index arrest
measure: Unexpected Adverse Event
timeFrame: Discharge or 30 days after index arrest
Locations:
city: Seattle
country: United States
facility: Graham Nichol
state: Washington
Study officials:
affiliation: University of Washington
name: Graham Nichol, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Emilby S Bartlett, MD MS
role: PRINCIPAL_INVESTIGATOR
References: