Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

Browse trials for

• Heart Arrest 984
• Reperfusion Injury 278

Keywords

• reperfusion injury
• remote ischemic conditioning

Heart Arrest

984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 563 interventional studies indexed under Heart Arrest.

Lead sponsor

University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Eligibility criteria

Study arms

• 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

• 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

Interventions

• DeviceActive 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.

• DeviceSham 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 outcomes

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. Renal Dysfunction

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

   Time frame: Within 24 hours of index arrest

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Accrual

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

    Time frame: Before leaving the emergency department

Other outcomes

1. Device Failure

   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.

   Time frame: 30 minutes from initiation of study intervention

2. Expected Adverse Event Related to Device- Pain

   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.

   Time frame: Within 24 hours of Enrollment

3. Expected Adverse Event Related to Device- Thrombophlebitis

   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.

   Time frame: Within 1 week of Enrollment

4. Expected Adverse Event Related to Device- Sepsis

   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.

   Time frame: Within 1 week of Enrollment

5. Expected Adverse Event Related to Cardiac 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.

   Time frame: Discharge or 30 days after index arrest

6. Unexpected Adverse Event

   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.

   Time frame: Discharge or 30 days after index arrest

Baseline characteristics

Study documents

• Study protocol · Aug 13, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Available upon request, subject to mutual agreement

Supporting information: Study protocol, Clinical study report