- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01413399
A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Therapeutic hypothermia improves mortality and functional neurologic outcomes in patients resuscitated from pulseless ventricular tachycardia and fibrillation (VT/VF), with several studies validating the safety of prehospital induction following successful (return of spontaneous circulation) ROSC by the rapid infusion of 2 liters of 4ºC intravenous fluids. However, the optimal timing for inducing hypothermia remains uncertain. Early studies demonstrated the efficacy of therapeutic hypothermia despite delays of 4 to 8 hours from the time of ROSC to the initiation of cooling. The post-resuscitation reperfusion injury evolves quickly and was thought to be best attenuated by hypothermia induction immediately following return of spontaneous circulation (ROSC). This was supported by animal data which demonstrated that improved neurologic outcome was associated with reduced time to goal temperature following ROSC. More recently this hypothesis has been called into question by 2 clinical trials which suggested that time to initiation of cooling was not associated with improved neurologic outcome at discharge.
There may be another benefit to early therapeutic cooling. Animal data suggest that intra-arrest induction of therapeutic hypothermia (IATH) improves rates of ROSC from cardiac arrest. This is corroborated by a report describing an impressively high ROSC rate of 60.9% among patients receiving IATH. This was a higher frequency of ROSC than reported in similar patient groups. It has been demonstrated that mild hypothermia exerts a stabilizing effect on the myocardium, decreasing the rate of refibrillation following ROSC. Mild hypothermia has also been shown to prolong ventricular refractoriness and repolarization, possibly facilitating electrical defibrillation by slowing repolarization ion currents.
Recently we conducted a retrospective observational study that demonstrated an association between the administration of IATH and ROSC.22 We found that the likelihood of ROSC with IATH was 2.4 (95% CI 1.41-4.24) time higher in the subset of patients who received > 700ml of 4º C normal saline compared to those who did not receive IATH. Our study lacked sufficient power to demonstrate a difference in survival to admission or discharge; however, we noted trends towards improved survival. Current intra-arrest treatments do not obtain ROSC rates greater than those seen in our study with IATH. These associations were noted in all rhythms, including asystole and pulseless electrical activity.
Obtaining ROSC quickly with the resulting decrease in time spent in a low or no flow circulation would have obvious downstream effects on both hospital mortality and neurologic function, independent of the effect of mild hypothermia in the post-arrest inflammatory state. Surprisingly these associations were seen even with fluid volumes that were too low to change core body temperature suggesting that the benefits of therapeutic hypothermia on the myocardium may be possible even at relatively low fluid volumes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28232
- Carolinas Medical Center; Center for Prehospital MEdicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cardiac arrest of presumed medical etiology in the out-of-hospital setting
Exclusion Criteria:
- Traumatic Cardiac Arrests
- Cardiac Arrests Due to hemorrhage
- Cardiac arrests involving children or young adults
- Patients presumed to be pregnant
- Patients with a do not resuscitate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intra-Arrest Therapeutic Hypothermia
|
4 degree chilled saline up to 2L in the prehospital setting
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Active Comparator: Post-Arrest Therapeutic Hypothermia
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4 degree chilled saline up to 2L in the prehospital setting
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Survived Up To Hospital Discharge
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
|
Adjusted OR and 95% CI
|
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Achieve Prehospital Return of Spontaneous Circulation
Time Frame: Patients will be followed for the duration of their prehospital course of care expected to be an average of 1 hour
|
ROSC will be defined as return of sustained pulses during the prehospital cardiac arrest resuscitation
|
Patients will be followed for the duration of their prehospital course of care expected to be an average of 1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jonathan R Studnek, PhD, Carolinas Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MeckHypo2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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