Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

Not Applicable

Completed

Conditions: Cardiac Arrest

Registration Number: NCT04265807

Lead Sponsor: University of Washington

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Attrition	Completion of their allocated study intervention, an average of 30 minutes from enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Success	30 minutes from initiation of study intervention	Treatment Success assessed as the proportion of intervention group patients who remain alive and on their allocated therapy for the intended study duration.
Cardiac Function	Within 48 hours of index arrest	Cardiac Function assessed as left ventricular ejection fraction (LVEF) using echocardiograms ordered for clinical indications.
Proportion With Cardiogenic Shock, %	Within 48 hours of index arrest	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.
STEMI	Within 48 hours of index arrest	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.
Myocardial Injury	Within 24 hours of index arrest	Myocardial Injury assessed as peak serum troponin in ng/mL at any time point within 24 h of index arrest.
Renal Dysfunction	Within 24 hours of index arrest	Renal Dysfunction assessed using Risk, Injury, Failure, Loss, End Stage criteria.
Hospital Free Survival	Within 30 days of index arrest	Hospital Free Survival (HFS) assessed as number of days alive and permanently out of hospital up to 30 days post arrest
Withdrawal of Care	Discharge or 30 days after index arrest	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.
Favourable Neurologic Status at Discharge	Discharge or 30 days after index arrest	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.
Survival to Discharge	Discharge or 30 days after index arrest	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.
Clinical Instability at Discharge	Discharge or 30 days after index arrest	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
Survival to 30 Days After Arrest	30 days after index 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.
Accrual	Before leaving the emergency department	Accrual is the proportion of eligible subjects who have the study device applied