A Pilot Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.

ZOLL Circulation, Inc., USA14 sites in 2 countries150 target enrollmentMarch 2014

ConditionsOut-Of-Hospital Cardiac Arrest

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Out-Of-Hospital Cardiac Arrest
Sponsor: ZOLL Circulation, Inc., USA
Enrollment: 150
Locations: 14
Primary Endpoint: Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

April 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ZOLL Circulation, Inc., USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent (obtained from their legal representative)
•18 years of age or older and less than 80 years old.
•Witnessed OHCA of presumed cardiac cause
•Sustained ROSC (when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist)
•Initial shockable cardiac rhythm (documented by ECG or AED)
•Interval from collapse to advance life support \< 20 minutes
•Interval from collapse to ROSC \< 60 minutes
•Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
•Systolic blood pressure of \>90 maintained for a least 30 minutes post-ROSC without pressors, or with a stable dose of pressors

Exclusion Criteria

•Traumatic cardiac arrest
•Toxicological etiology
•Known or suspected pregnancy
•Do Not Attempt to Resuscitate order in force
•Unwitnessed arrest
•In-Hospital arrest
•Anatomy, previous surgery or disease state contraindicating femoral venous access
•Received neuromuscular blocking agents prior to assessing level of consciousness following ROSC
•Neurological evaluation insufficient/incomplete after ROSC but prior to randomization.
•Body core temperature \< 34ºC at randomization

Outcomes

Primary Outcomes

Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.

Time Frame: at 90 days after out-of-hospital cardiac arrest

Secondary Outcomes

Observational status of arrest(Witnessed by EMS; Witnessed by bystanders)
Outcomes: 1.Favorable neurologic status at 90 days (i.e. mRS < 3) measured as proportion(90 days)
Outcomes: 8. Hospital-free survival within 90 days measured in days(90 days)
Treatment Success: 2. proportion of time at randomly allocated target temperature ±0.3°C during first 24 hours after initiation of induction of hypothermia(24 hours)
Outcomes: 3.Robust neurologic status at 90 days (i.e. mRS < 2) measured as proportion(90 days)
Treatment Success: 3. time to randomly allocated target temperature, from call to 911, sustained restoration of circulation and initiation of induction of hypothermia(26 hours)
Outcomes: 2.Time to first detected mRS ≤3 (i.e. Kaplan Meier curve)(90 days)
Outcomes: 6. Cumulative incidence of survival at 90 days (i.e. Kaplan Meier curve)(90 days)
Outcomes: 4. Time to first detected mRS ≤2 (i.e. Kaplan Meier curve)(90 days)
Treatment Success: 5. rate of rewarming in °C per hour(Per hour)
Subgroups of Special Interest Age of Patients(Duration of the trial)
Treatment Success: 1. proportion of subjects that can be therapeutically cooled to randomly allocated target temperature ±0.3°C (as measured by the temperature probe)(24 hours)
Treatment Success: 4. rate of cooling in °C per hour(Per hour)
Outcomes: 5. Survival at 90 days measured as proportion(90 days)
Outcomes: 7. ICU-free survival within 90 days measured in days(90 days)
Outcomes: 9. Adverse events a. Device related b. Procedure related(90 days)
Subgroup analysis(1 year)
Timings of initiation of hypothermia(<4 hours of restoration of spontaneous circulation; or > 4 hours)
Patient Gender(Male or Female)
Response time interval from call to initiation of CPR by EMS, among witnessed arrests:(< 10 minutes;> 10 minutes.)
Location of cardiac arrest(Public;Home; or Group residence (e.g. nursing home))
Bystander CPR status:(Performed; or Not performed.)
AED status:(Applied by layperson;Applied by EMS provider;Not applied)