Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

University of Washington30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardiac Arrest

Interventions

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.

Sham Remote Ischemic ConditioningDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Treatment Success

Treatment Success assessed as the proportion of intervention group patients who remain alive and on their allocated therapy for the intended study duration.

Time frame: 30 minutes from initiation of study intervention

Cardiac Function

Cardiac Function assessed as left ventricular ejection fraction (LVEF) using echocardiograms ordered for clinical indications.

Time frame: Within 48 hours of index arrest

Proportion With Cardiogenic Shock, %

Cardiogenic Shock assessed as systolic BP \< 80 mmHg during any 6 h period within 48 h of the index arrest not due to a correctable cause, and treated with pressors or inotropes or placement of a mechanical cardiac assist device (e.g. intra-aortic balloon pump). Cardiogenic shock correlates with survival after resuscitation from cardiac arrest.

Time frame: Within 48 hours of index arrest

STEMI

STEMI assessed as the presence of electrocardiographic (ECG) and biomarker criteria for acute myocardial infarction within 48 h of the index arrest. Note that ST-elevation on the first 12-lead ECG after resuscitation is a poor predictor of acute infarction in this population. These patients often develop infarctions during the subsequent 48 h.

Time frame: Within 48 hours of index arrest

Myocardial Injury

Myocardial Injury assessed as peak serum troponin in ng/mL at any time point within 24 h of index arrest.

Time frame: Within 24 hours of index arrest

Renal Dysfunction

Renal Dysfunction assessed using Risk, Injury, Failure, Loss, End Stage criteria.

Time frame: Within 24 hours of index arrest

Hospital Free Survival

Hospital Free Survival (HFS) assessed as number of days alive and permanently out of hospital up to 30 days post arrest

Time frame: Within 30 days of index arrest

Withdrawal of Care

assessed as the reduction of support (i.e. reducing pressors, lab draws or medications) or withdrawal of support (i.e. extubation, stopping drips/meds, changing to comfort care only) during hospitalization.

Time frame: Discharge or 30 days after index arrest

Favourable Neurologic Status at Discharge

Favourable Neurologic Status at Discharge assessed using modified Rankin Score (MRS) \< 3 at hospital discharge or 30 days after index arrest. Modified Rankin Scale is scored from zero to six. Higher values represent a worse outcome. Favorable neurologic status is defined as a modified Rankin score 0, 1 or 2.

Time frame: Discharge or 30 days after index arrest

Survival to Discharge

Survival to Discharge assessed as alive when discharged from hospital to home, nursing facility or rehabilitation. Patients transferred to another acute care facility (e.g. to undergo implantable defibrillator placement) will be considered still hospitalized.

Time frame: Discharge or 30 days after index arrest

Clinical Instability at Discharge

Clinical Instability at Discharge assessed using the Kosecoff Index measured at discharge based on the presence of nine symptoms and signs associated with increased risk of rehospitalization. Instability will be the presence of any of these. Clinical instability at discharge was defined by the Kosecoff Index. https://pubmed.ncbi.nlm.nih.gov/2214063/ This was scored as 1 point for the presence and 0 for the absence of each of the following during the 24 h prior to discharge: Fever, temperature \>38.3°C Urinary incontinence Chest pain Shortness of breath Confusion Heart rate \>=130 beats/min Respiratory rate \>=30/min Diastolic blood pressure \>= 105 mmHg Systolic blood pressure \< 90 mmHg Heart rate \< 50 bpm Premature ventricular contractions on telemetry

Time frame: Discharge or 30 days after index arrest

Survival to 30 Days After Arrest

Survival to 30 Days After Cardiac Arrest assessed as alive 30 days after the index cardiac arrest as confirmed by a brief telephone interview.

Time frame: 30 days after index arrest

Accrual

Accrual is the proportion of eligible subjects who have the study device applied

Time frame: Before leaving the emergency department

Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes