NCT04265807

Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

Completed NA Results posted Last updated 4 February 2025

What this trial tests

NA trial testing Active Remote Ischemic Conditioning in Cardiac Arrest in 30 participants. Completed in 3 February 2022.

Timeline

1 July 2020

Primary endpoint
3 February 2022

3 February 2022

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 July 2020
Primary completion	3 February 2022
Estimated completion	3 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Active Remote Ischemic Conditioning
• Sham Remote Ischemic Conditioning

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Attrition Primary · 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.

Group	Value	95% CI
Intervention Group	0
Control Group	0

Treatment Success Secondary · 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.

Group	Value	95% CI
Intervention Group	16
Control Group	14

Cardiac Function Secondary · Within 48 hours of index arrest

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

Group	Value	95% CI
Intervention Group	48.4	± 20
Control Group	51.7	± 12.8

Proportion With Cardiogenic Shock, % Secondary · 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.

Group	Value	95% CI
Intervention Group	13
Control Group	11

STEMI Secondary · 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.

Group	Value	95% CI
Intervention Group	0
Control Group	0

Myocardial Injury Secondary · 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.

Group	Value	95% CI
Intervention Group	3.7	± 8.9
Control Group	7.4	± 16.2

Renal Dysfunction Secondary · Within 24 hours of index arrest

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

Group	Value	95% CI
Intervention Group	4
Control Group	2

Hospital Free Survival Secondary · 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

Group	Value	95% CI
Intervention Group	11.1	± 14.3
Control Group	7.3	± 12.3

Withdrawal of Care Secondary · 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.

Group	Value	95% CI
Intervention Group	6
Control Group	7

Favourable Neurologic Status at Discharge Secondary · 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.

Group	Value	95% CI
Intervention Group	6	1 – 6
Control Group	6	1.5 – 6

Survival to Discharge Secondary · 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.

Group	Value	95% CI
Intervention Group	7
Control Group	6

Clinical Instability at Discharge Secondary · 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

Group	Value	95% CI
Intervention Group	3
Control Group	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days after cardiac arrest.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group

Serious: 0/16 (0%)

Deaths: 9/16

Control Group

Serious: 0/14 (0%)

Deaths: 8/14

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention Group	Control Group
Temporary occlusion of IV in the Emergency Department	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT04265807 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. mRNA Vaccine Effectiveness Against Coronavirus Disease 2019 Hospitalization Among Solid Organ Transplant Recipients.
   Kwon JH, Kwon JH, Tenforde MW, Gaglani M, et al · · 2022 · cited 32× · PMID 35385875 · DOI 10.1093/infdis/jiac118