Recruiting
Phase 2
Phase 3

Observational Study

Sponsor:

Carol Bernier

Code:

NCT05283850

Conditions

Cardiac Arrest

Pulseless Electrical Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Calcium, Low Sodium (HCLS) Crystalloid Therapy

High Calcium, High Sodium (HCHS) Crystalloid Therapy

Study Details

Brief 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

Cardiac Arrest

Pulseless Electrical Activity

Study ID

NCT05283850

Start date

Feb 16, 2022

Status verified date

Mar, 2022

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients who present with PEA at any time during the patients' treatment by Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and/or Salem Fire-EMS. This study defines a PEA presentation as any patient who is unconscious, presenting without a carotid pulse and with non-(VT/VF) ventricular tachycardia/ventricular fibrillation electrical activity.

Exclusion Criteria:

  • Patient less than 18 years old
  • Known pregnancy
  • Duration of untreated cardiac arrest of more than 30 minutes
  • Traumatic cardiac arrest
  • Known (LVAD) Left Ventricular Assist Device
  • Rapidly fatal underlying disease
  • Known or suspected digitalis toxicity
  • A physical, durable (DNR) Do Not Resuscitate (or durable DNR medical jewelry) presented to EMS before treatment with asserting a preference not to be enrolled
  • Prisoners and other populations with involuntary consent

Study Design

Enrollment

342 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: High-Calcium, High- Sodium (HCHS) group

Patients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.

experimental: High-Calcium, Low- Sodium (HCLS) group

Patients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.

Interventions

High Calcium, Low Sodium (HCLS) Crystalloid Therapy

Half-normal saline IV drip and 1g IV bolus Calcium Chloride.

High Calcium, High Sodium (HCHS) Crystalloid Therapy

Normal saline IV drip and 1g IV bolus Calcium Chloride.

Primary outcome measure

  • Event Survival [ Time Frame: Up to 1 hour ]

Central Contacts and Locations

Central contacts

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

More Information

Sponsor

Carol Bernier

Last update posted

Mar 17, 2022

Last verified

Mar, 2022

Keywords

  • Crystalloid Fluids
  • Emergency Medical Services (EMS)
  • Pre-Hospital Medicine
  • Sodium Chloride
  • Calcium Chloride
  • Normal Saline
  • Half-Normal Saline
  • Waiver of Informed Consent
  • Paramedic
  • Electrolyte

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carol Bernier on 2022-03-17.