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Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

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ClinicalTrials.gov Identifier: NCT04265807
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
Kettering Foundation
ZOLL Foundation
Information provided by (Responsible Party):
Graham Nichol, 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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: Active Remote Ischemic Conditioning Device: Sham Remote Ischemic Conditioning Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Patients and investigators will be masked to treatment assignment up to the point of randomization.
Primary Purpose: Treatment
Official Title: Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot
Estimated Study Start Date : February 7, 2020
Estimated Primary Completion Date : August 7, 2020
Estimated Study Completion Date : January 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Active Comparator: Intervention Group
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
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 Comparator: Control Group
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
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.




Primary Outcome Measures :
  1. Attrition [ Time Frame: 30 minutes from initiation of study intervention ]
    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 :
  1. Treatment Success [ Time Frame: 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.

  2. Cardiac Function [ Time Frame: Within 48 hours of index arrest ]
    Cardiac Function assessed as left ventricular ejection fraction (LVEF) using echocardiograms ordered for clinical indications.

  3. Cardiogenic Shock [ Time Frame: 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.

  4. STEMI [ Time Frame: 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.

  5. Myocardial Injury [ Time Frame: 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.

  6. Renal Dysfunction [ Time Frame: Within 24 hours of index arrest ]
    Renal Dysfunction assessed using Risk, Injury, Failure, Loss, End Stage criteria.

  7. Hospital Free Survival [ Time Frame: 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

  8. Withdrawal of Care [ Time Frame: 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.

  9. Favourable Neurologic Status at Discharge [ Time Frame: 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.

  10. Survival to Discharge [ Time Frame: Dicharge 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.

  11. Clinical Instability at Discharge [ Time Frame: 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.

  12. Survival to 30 days after arrest [ Time Frame: 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.

  13. Accrual [ Time Frame: Through study completion, an average of 6 mos. ]
    Accrual is the proportion of eligible subjects who have the study device applied


Other Outcome Measures:
  1. Device Failure [ Time Frame: 30 minutes from initiation of study intervention ]
    device failure will be defined as discontinuation of use of the device prior to the end of allocated treatment interval because of mechanical failure as opposed to provider preference.

  2. Expected Adverse Event Related to Device- Pain [ Time Frame: Within 24 hours of Enrollment ]
    Pain assessed using the Richmond Agitation-Sedation Scale at 30 and 60 minutes after randomization in control and intervention group patients. No gold standard exists for pain assessment in sedated and ventilated patients.

  3. Expected Adverse Event Related to Device- Thrombophlebitis [ Time Frame: Within 1 week of Enrollment ]
    Thrombophlebitis assessed as symptomatic non central nervous system venous or arterial thrombus documented radiographically or ultrasonographically in the upper extremity to which the study intervention was applied.

  4. Expected Adverse Event Related to Device- Sepsis [ Time Frame: Within 1 week of Enrollment ]
    Sepsis assessed within one week of index arrest as either i) the presence of microbiologically proven, clinically proven, or suspected infection; or ii) presence of Systemic Inflammatory Response Syndrome (SIRS); and iii) development of at least one organ dysfunction within the preceding 24 hours.

  5. Expected Adverse Event Related to Cardiac Arrest [ Time Frame: Discharge or 30 days after index arrest ]
    Related to Cardiac Arrest The following are commonly observed in patients who experience cardiac arrest, and may or may not be attributable to specific resuscitation therapies. These will be monitored and reported but not classified as serious adverse events. Clinical diagnoses of pneumonia, cerebral bleeding, stroke, seizures, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, serious rib fractures, sternal fractures, internal thoracic or abdominal injuries as noted in the hospital discharge summary.

  6. Unexpected Adverse Event [ Time Frame: Discharge or 30 days after index arrest ]
    These will be defined as any serious unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in the investigation plan or application, or any other unexpected serious problem associated with a device that relates to the rights, safety or welfare of subjects. Death or neurological impairment will not be considered an adverse event in this study, as it is an expected part of the natural history of the illness for a large proportion of the population.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265807


Contacts
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Contact: Graham Nichol, MD, MPH 206-521-1722 ricstudy@uw.edu
Contact: Emily Bartlett, MD 206 521 1722 ricstudy@uw.edu

Locations
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United States, Washington
Graham Nichol Recruiting
Seattle, Washington, United States, 98104
Contact: Graham Nichol, MD MPH    206-521-1722    ricstudy@uw.edu   
Contact: Emily S Bartlett, MD MS       ricstudy@uw.edu   
Sponsors and Collaborators
University of Washington
Kettering Foundation
ZOLL Foundation
Investigators
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Principal Investigator: Graham Nichol, MD, MPH University of Washington
Principal Investigator: Emilby S Bartlett, MD MS University of Washington

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Responsible Party: Graham Nichol, Professor, School of Medicine: Department of Medicine: General Internal Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT04265807    
Other Study ID Numbers: STUDY00005176
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available upon request, subject to mutual agreement
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graham Nichol, University of Washington:
reperfusion injury
remote ischemic conditioning
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases