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NCT05283850 · ClinicalTrials.gov registry record · Phase 2
Surviving PEA in Roanoke (SPEAR) Study
A Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity, sponsored by Carol Bernier.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 342
- Enrollment target
- 1
- Study location
NCT05283850 is a Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity that is actively recruiting participants, run by Carol Bernier. The registered enrollment target is 342 participants, below the 1,469-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05283850, a Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity, is actively recruiting participants, sponsored by Carol Bernier.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 342 participants
- Enrollment target
- 1
- Study location
Study Summary
The Carilion Clinic and Virginia Tech Carilion School of Medicine, in conjunction with Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS, are studying the outcomes of patients experiencing Pulseless Electrical Activity (PEA). PEA refers to a type of cardiac arrest in which there is normal electrical activity in the heart however the heart still fails to contract to generate a pulse. Without heart contractions, which normally generates a pulse, the brain and other important organs fail to receive blood and oxygen. Unfortunately, the majority (97.3%) of patients that experience this rhythm do not survive and most don't even make it to the hospital. This study is trying to determine if the administration of a High Calcium, Low Sodium (HCLS) fluid in pre-hospital care will improve the chances of survival. Generally, a sodium (salt) solution is provided to patients experiencing cardiac arrest. Studies have shown that lower sodium and higher calcium content may activate certain parts of the heart cells required to generate a pulse under PEA conditions. This study is a double-blind, prospective, clinical trial. PEA patients will randomly receive either routine fluid therapy (salt solution) or a HCLS solution. While HCLS solution is not the standard fluid used by EMS providers responding to PEA, it is composed of FDA approved components and is occasionally used by EMS providers at their discretion in treating PEA. It is predicted that HCLS will either improve PEA survival or deliver similar outcomes as routine treatment. All patients will receive standard, high quality cardiac arrest and post-cardiac arrest care regardless of assigned treatment group.
Conditions Studied
Interventions
- DRUG High Calcium, Low Sodium (HCLS) Crystalloid Therapy
- DRUG High Calcium, High Sodium (HCHS) Crystalloid Therapy
Study Locations (1)
Virginia
- Carilion Clinic - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05283850
The ClinicalTrials.gov registry entry for NCT05283850 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 342 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,469-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (77% lower). The listed sponsor is Carol Bernier, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiac Arrest appearing as the primary indexed condition, and to 2 interventions - of which High Calcium, Low Sodium (HCLS) Crystalloid Therapy is the first listed.
NCT05283850 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT05283850 about?
NCT05283850 is a clinical study titled "Surviving PEA in Roanoke (SPEAR) Study". The Carilion Clinic and Virginia Tech Carilion School of Medicine, in conjunction with Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS, are studying the outcomes of patients experiencing Pulseless Electrical Activity (PEA). PEA refers to a type of cardiac arrest in wh...
What is the current status of trial NCT05283850?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2022-02-16. Estimated completion is 2027-02.
What conditions does trial NCT05283850 study?
This clinical trial studies the following conditions: Cardiac Arrest, Pulseless Electrical Activity.
What interventions are being tested in trial NCT05283850?
The interventions under investigation include: High Calcium, Low Sodium (HCLS) Crystalloid Therapy (DRUG), High Calcium, High Sodium (HCHS) Crystalloid Therapy (DRUG).
Who is sponsoring clinical trial NCT05283850?
This trial is sponsored by Carol Bernier, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05283850 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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