Risk Stratification of Patients Presenting With Cardiac Arrest
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Essentia Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Death from any cause
Study Overview
Brief Summary
Method: Single center, prospective, non-randomized, unblinded case series of all patients presenting with a cardiac arrest. The proposed study will collect data on all comatose patients presenting with cardiac arrest. The primary end point is death from any cause at 30 days from admission.
Significance: Develop criteria to guide an invasive strategy for comatose patients presenting with cardiac arrest, and so avoid ineffective or even futile therapy which carry its own significant risks for patients in the future. The criteria, in turn, can serve as the basis for a prospective, randomized trial in the future.
Detailed Description
Research Design and Methods:
General Approach: This study is a prospective, non-randomized, unblinded case series of comatose patients presenting with cardiac arrest to either Essentia East (St. Mary's Medical Center or Miller-Dwan Medical Center) or Essentia West (Innovis Health).
Methods and Materials: Patients will be enrolled over a 60-month period by the PI, Sub-I, or study coordinator. The enrollment goal is 100 patients. The study will collect demographic, clinical and outcome data on comatose patients presenting with cardiac arrest only, and does not prescribe any clinical testing or therapies including PCI or hypothermia. All clinical decisions are left to the discretion of the attending providers.
Consent Process: This study will seek a waiver for informed consent as the patients, by study inclusion criteria, will not be able to provide informed consent, and this study uses a minimal risk design. In the spirit of transparency, attempts will be made to inform the patient, patient representative or family when possible of enrollment in the study within 48 hours of enrollment. The patient or appropriate patient representative identified from the EMR will be spoke to in person or by phone by the PI, sub-PI, or study coordinator.21 The patient and/or family will then have the opportunity to decline participation in the study. The conversation will be documented in the medical record by the PI, sub-PI or study coordinator.
Randomization Process: The study is a prospective, non-randomized, unblinded case series. Patient will be followed as a single cohort, and no randomization is required.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to 18 years
- •Presumed cardiac etiology of arrest
- •GCS ≤ 819,20
- •Initial presentation to an outside facility or to the emergency room of the receiving facility.
Exclusion Criteria
- •Presumed non-cardiac etiology of arrest including trauma, pulmonary embolus, sepsis, respiratory failure.
- •Transfer time from arrest to receiving facility greater than 12 hours
- •Cardiac arrest occurring after admission to either the outside facility or receiving facility.
- •Patient pronounced dead prior to arrival to the receiving facility emergency room.
Outcomes
Primary Outcomes
Death from any cause
Time Frame: 30 days
Death from any cause at 30 days from admission
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Mollerus
MD
Essentia Health