A Phase 2/3 interventional study of Rapid infusion of 2 liters of 4oC normal saline and Rapid infusion of cold normal saline in Out-of-hospital Cardiac Arrest, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by University of Washington · Phase 2/3, Interventional, and Treatment
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.
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 1,359 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
Other: Rapid infusion of 2 liters of 4oC normal saline · Drug: Rapid infusion of cold 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.
Also known as: Rapid infusion of cold normal saline
Number Alive at Hospital Discharge
Time frame: at hospital discharge
Neurologic Status at Discharge-full Recovery
Time frame: at time of discharge
| Milestone | Intervention | Control |
|---|---|---|
| Started | 688 | 671 |
| Completed | 688 | 671 |
| Not completed | 0 | 0 |
| participants | VF-randomized to Standard Treatment | VF-randomized to Hypothermia | Non-VF Randomized to Standard Treatment | Non-VF-randomized to Hypothermia |
|---|---|---|---|---|
| Number Alive at Hospital Discharge | 187 | 183 | 62 | 76 |
| participants | VF-randomized to Standard Treatment | VF-randomized to Hypothermia | Non-VF Randomized to Standard Treatment | Non-VF-randomized to Hypothermia |
|---|---|---|---|---|
| Neurologic Status at Discharge-full Recovery | 145 | 125 | 34 | 36 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention-hypo | — | 547/688 (79.5%) | 0/688 (0%) |
| Control-standard Care | — | 513/671 (76.5%) | 0/671 (0%) |
| Event | Intervention-hypo | Control-standard Care |
|---|---|---|
| pulmonary edema on first chest X-rayCardiac disorders | 256/631 | 184/609 |
| Re-arrest postrandomizationCardiac disorders | 176/686 | 138/671 |
| use of diuretics first 12 hCardiac disorders | 119/674 | 81/648 |
| death in emergency dept.Cardiac disorders | 88/688 | 85/671 |
| Use of pressers post randomizationCardiac disorders | 62/686 | 59/671 |
| prehospital deathsCardiac disorders | 9/688 | 11/671 |
| Age, Continuous(years) | VF-randomized to Standard Treatment | VF-randomized to Hypothermia | Non-VF Randomized to Standard Treatment | Non-VF-randomized to Hypothermia | Total |
|---|---|---|---|---|---|
| Mean | 62.1 ± 15.6 | 62.1 ± 14.2 | 67.5 ± 16.5 | 68.3 ± 16.3 | 65.1 ± 15.3 |
| Sex: Female, Male(Participants) | VF-randomized to Standard Treatment | VF-randomized to Hypothermia | Non-VF Randomized to Standard Treatment | Non-VF-randomized to Hypothermia | Total |
|---|---|---|---|---|---|
| Female | 74 | 65 | 175 | 180 | 494 |
| Male | 217 | 227 | 205 | 216 | 865 |
| Region of Enrollment(participants) | VF-randomized to Standard Treatment | VF-randomized to Hypothermia | Non-VF Randomized to Standard Treatment | Non-VF-randomized to Hypothermia | Total |
|---|---|---|---|---|---|
| United States | 291 | 292 | 380 | 396 | 1359 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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