Out-of-hospital Cardiac Arrest
Conditions
Keywords
cardiac arrest, mild hypothermia
Brief summary
The overall goal of this study is to determine whether initiating hypothermia in cardiac arrest patients as soon as possible in the field results in a greater proportion of patients who survive to hospital discharge compared to standard prehospital/field care.
Detailed description
In this study we will randomize 1,200 cardiac arrest patients who have return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objective of this study will be to determine whether induction of mild hypothermia using an infusion of cold normal saline will improve the proportion of patients who survive and are discharged awake from the hospital. Hypothesis: In cardiac arrest patients who achieve ROSC in the field, initiation of hypothermia by infusion of cold normal saline will result in a greater proportion of cardiac arrest patients discharged awake from the hospital compared to standard care.
Interventions
OTHERRapid infusion of 2 liters of 4oC normal saline
Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
DRUGRapid infusion of cold normal saline
Sponsors
University of Washington
Medic One Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse
Exclusion criteria
* traumatic cause for cardiac arrest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number Alive at Hospital Discharge | at hospital discharge |
Secondary
| Measure | Time frame |
|---|---|
| Neurologic Status at Discharge-full Recovery | at time of discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VF-randomized to Standard Treatment standard treatment following VF cardiac arrest | 291 |
| VF-randomized to Hypothermia Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline | 292 |
| Non-VF Randomized to Standard Treatment standard treatment following non-VF cardiac arrest | 380 |
| Non-VF-randomized to Hypothermia Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Rapid infusion of cold normal saline | 396 |
| Total | 1,359 |
Baseline characteristics
| Characteristic | VF-randomized to Standard Treatment | VF-randomized to Hypothermia | Non-VF Randomized to Standard Treatment | Non-VF-randomized to Hypothermia | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 15.6 | 62.1 years STANDARD_DEVIATION 14.2 | 67.5 years STANDARD_DEVIATION 16.5 | 68.3 years STANDARD_DEVIATION 16.3 | 65.1 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment United States | 291 participants | 292 participants | 380 participants | 396 participants | 1359 participants |
| Sex: Female, Male Female | 74 Participants | 65 Participants | 175 Participants | 180 Participants | 494 Participants |
| Sex: Female, Male Male | 217 Participants | 227 Participants | 205 Participants | 216 Participants | 865 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 688 | 0 / 671 |
| serious Total, serious adverse events | 547 / 688 | 513 / 671 |
Outcome results
Primary
Number Alive at Hospital Discharge
Time frame: at hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VF-randomized to Standard Treatment | Number Alive at Hospital Discharge | 187 participants |
| VF-randomized to Hypothermia | Number Alive at Hospital Discharge | 183 participants |
| Non-VF Randomized to Standard Treatment | Number Alive at Hospital Discharge | 62 participants |
| Non-VF-randomized to Hypothermia | Number Alive at Hospital Discharge | 76 participants |
Secondary
Neurologic Status at Discharge-full Recovery
Time frame: at time of discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VF-randomized to Standard Treatment | Neurologic Status at Discharge-full Recovery | 145 participants |
| VF-randomized to Hypothermia | Neurologic Status at Discharge-full Recovery | 125 participants |
| Non-VF Randomized to Standard Treatment | Neurologic Status at Discharge-full Recovery | 34 participants |
| Non-VF-randomized to Hypothermia | Neurologic Status at Discharge-full Recovery | 36 participants |