A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
Primary Purpose
Out-of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4 degree chilled saline
Sponsored by
About this trial
This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest
Eligibility Criteria
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
Sites / Locations
- Carolinas Medical Center; Center for Prehospital MEdicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intra-Arrest Therapeutic Hypothermia
Post-Arrest Therapeutic Hypothermia
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Who Survived Up To Hospital Discharge
Adjusted OR and 95% CI
Secondary Outcome Measures
Number of Patients Who Achieve Prehospital Return of Spontaneous Circulation
ROSC will be defined as return of sustained pulses during the prehospital cardiac arrest resuscitation
Full Information
NCT ID
NCT01413399
First Posted
August 9, 2011
Last Updated
June 2, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01413399
Brief Title
A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
Official Title
A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study will be to assess the frequency of return of spontaneous circulation (ROSC), survival to admission, survival to discharge from the hospital, and neurologic function at time of discharge from the hospital among patients experiencing out of hospital cardiac arrest randomized to receive either intra-arrest induction of therapeutic hypothermia (IATH) or post-arrest therapeutic hypothermia (TH).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
542 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra-Arrest Therapeutic Hypothermia
Arm Type
Active Comparator
Arm Title
Post-Arrest Therapeutic Hypothermia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
4 degree chilled saline
Intervention Description
4 degree chilled saline up to 2L in the prehospital setting
Primary Outcome Measure Information:
Title
Number of Participants Who Survived Up To Hospital Discharge
Description
Adjusted OR and 95% CI
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Who Achieve Prehospital Return of Spontaneous Circulation
Description
ROSC will be defined as return of sustained pulses during the prehospital cardiac arrest resuscitation
Time Frame
Patients will be followed for the duration of their prehospital course of care expected to be an average of 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan R Studnek, PhD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center; Center for Prehospital MEdicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21036449
Citation
Garrett JS, Studnek JR, Blackwell T, Vandeventer S, Pearson DA, Heffner AC, Reades R. The association between intra-arrest therapeutic hypothermia and return of spontaneous circulation among individuals experiencing out of hospital cardiac arrest. Resuscitation. 2011 Jan;82(1):21-5. doi: 10.1016/j.resuscitation.2010.09.473. Epub 2010 Oct 30.
Results Reference
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A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
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