Influence of cooling duration on efficacy in cardiac patients (ICECAP Study)
B
Benton Hunter, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
2 Locations
Brief description of study
To characterize the duration response curve for hypothermia and determine in each of two populations:
A. the shortest duration of cooling that provides the maximal treatment effect, and
B. whether the duration-response implies efficacy versus no cooling
A. the shortest duration of cooling that provides the maximal treatment effect, and
B. whether the duration-response implies efficacy versus no cooling
This study is enrolling comatose adult survivors of out of hospital cardiac arrest that have already been rapidly cooled using a definitive temperature control method (endovascular or surface) will be enrolled in the emergency department or intensive care unit.
Inclusion: Coma after resuscitation from out of hospital cardiac arrest, >18 years of age, <34 deg C within 240 minutes, definitive temperature control device applied, Informed consent from LAR including intent to maintain life support for 96 hours, enrollment within 6 hours of initiation of cooling
Exclusion: Hemodynamic instability, pre-existing condition confounding outcome determination, pre-existing terminal illness, unlikely to survive to outcome determination, planned early withdrawal of life support, presumed sepsis as etiology of arrest, prisoner
Exclusion: Hemodynamic instability, pre-existing condition confounding outcome determination, pre-existing terminal illness, unlikely to survive to outcome determination, planned early withdrawal of life support, presumed sepsis as etiology of arrest, prisoner
Detailed description of study
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.
Cardiac arrest is a common and devastating emergency of the heart and the brain. More than 380,000 patients suffer out of hospital cardiac arrest (OHCA) each year in the US. Improvements in cardiac resuscitation (the early links in the “chain of survival” for patients with OHCA) are tempered by our limited ability to resuscitate and protect the brain from global cerebral ischemia.
Neurological death and disability are common outcomes in survivors of cardiac arrest. Therapeutic cooling of comatose patients resuscitated from shockable rhythms markedly increases the rate of good neurological outcome, but poor outcomes still occur in as many as 50%, and the benefit of cooling in those resuscitated from asystole and pulseless electrical activity has not been shown in a randomized study.
Cardiac arrest is a common and devastating emergency of the heart and the brain. More than 380,000 patients suffer out of hospital cardiac arrest (OHCA) each year in the US. Improvements in cardiac resuscitation (the early links in the “chain of survival” for patients with OHCA) are tempered by our limited ability to resuscitate and protect the brain from global cerebral ischemia.
Neurological death and disability are common outcomes in survivors of cardiac arrest. Therapeutic cooling of comatose patients resuscitated from shockable rhythms markedly increases the rate of good neurological outcome, but poor outcomes still occur in as many as 50%, and the benefit of cooling in those resuscitated from asystole and pulseless electrical activity has not been shown in a randomized study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: coma
-
Age: Between 18 Years - 100 Years
-
Gender: All
Coma after resuscitation from out of hospital cardiac arrest
Cooled to <34 deg C within 240 minutes of cardiac arrest
Definitive temperature control device initiated
Enrollment within 6 hours of initiation of cooling
Age ≥ 18 years
Informed consent from LAR including intent to maintain life support for 96 hours
Cooled to <34 deg C within 240 minutes of cardiac arrest
Definitive temperature control device initiated
Enrollment within 6 hours of initiation of cooling
Age ≥ 18 years
Informed consent from LAR including intent to maintain life support for 96 hours
Updated on
01 Aug 2024.
Study ID: 2002511488
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