Trial Outcomes & Findings for A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest (NCT NCT01413399)
NCT ID: NCT01413399
Last Updated: 2022-06-28
Results Overview
Adjusted OR and 95% CI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
542 participants
Primary outcome timeframe
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Intra-Arrest Therapeutic Hypothermia
4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
|
Post-Arrest Therapeutic Hypothermia
4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
|
|---|---|---|
|
Overall Study
STARTED
|
208
|
334
|
|
Overall Study
COMPLETED
|
208
|
334
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
Baseline characteristics by cohort
| Measure |
Intra-Arrest Therapeutic Hypothermia
n=208 Participants
4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
|
Post-Arrest Therapeutic Hypothermia
n=334 Participants
4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
|
Total
n=542 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
n=5 Participants
|
63.9 years
n=7 Participants
|
64.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
208 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 5 weeksAdjusted OR and 95% CI
Outcome measures
| Measure |
Intra-Arrest Therapeutic Hypothermia
n=208 Participants
4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
|
Post-Arrest Therapeutic Hypothermia
n=334 Participants
4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
|
|---|---|---|
|
Number of Participants Who Survived Up To Hospital Discharge
|
24 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Patients will be followed for the duration of their prehospital course of care expected to be an average of 1 hourROSC will be defined as return of sustained pulses during the prehospital cardiac arrest resuscitation
Outcome measures
| Measure |
Intra-Arrest Therapeutic Hypothermia
n=208 Participants
4 degree chilled saline: 4 degree chilled saline up to 2L in the prehospital setting
|
Post-Arrest Therapeutic Hypothermia
n=334 Participants
4 degree chilled saline: 4 degree chilled saline up to 2L in the hospital setting
|
|---|---|---|
|
Number of Patients Who Achieve Prehospital Return of Spontaneous Circulation
|
76 Participants
|
90 Participants
|
Adverse Events
Intra-Arrest Therapeutic Hypothermia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-Arrest Therapeutic Hypothermia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place