Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP)
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain
About this trial
This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma
Eligibility Criteria
Inclusion Criteria:
- Coma after resuscitation from out of hospital cardiac arrest
- Cooled to <34 deg C with 240 minutes of cardiac arrest
- Definitive temperature control applied
- Age ≥ 18 years
- Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours
- Enrollment within 6 hours of initiation of cooling
Exclusion Criteria:
- Hemodynamic instability
- Pre-existing neurological disability or condition that confounds 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
Sites / Locations
- University of Alabama HospitalRecruiting
- Banner University Medical CenterRecruiting
- Cedars-Sinai Medical CenterRecruiting
- Ronald Regan UCLA Medical CenterRecruiting
- UC Davis Medical CenterRecruiting
- UC San Diego Medical Center - HillcrestRecruiting
- Zuckerberg San Francisco General HospitalRecruiting
- Stanford University Medical CenterRecruiting
- Harbor-UCLA Medical CenterRecruiting
- University of Colorado HospitalRecruiting
- Denver Health Medical CenterRecruiting
- Yale New Haven HospitalRecruiting
- UF Health Shands HospitalRecruiting
- Grady Memorial HospitalRecruiting
- The Queen's Medical CenterRecruiting
- Northwestern Memorial HospitalRecruiting
- Rush University Medical CenterRecruiting
- University of Illinois-Chicago HosptialRecruiting
- University of Chicago Medical CenterRecruiting
- Advocate Christ Medical CenterRecruiting
- IU Health Methodist HospitalRecruiting
- University of Kentucky HospitalRecruiting
- Maine Medical CenterRecruiting
- University of Maryland Medical CenterRecruiting
- Johns Hopkins HospitalRecruiting
- Massachusetts General HospitalRecruiting
- Brigham & Women's HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- University of Michigan HospitalRecruiting
- Detroit Receiving HospitalRecruiting
- Henry Ford HospitalRecruiting
- DMC Sinai Grace HospitalRecruiting
- Spectrum Health Butterworth HospitalRecruiting
- William Beaumont HospitalRecruiting
- M Health Fairview Southdale HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- M Health Fairview East Bank HospitalRecruiting
- Regions HospitalRecruiting
- University of Nebraska Medical CenterRecruiting
- Cooper University HospitalRecruiting
- Kings County Hospital CenterRecruiting
- NYP Columbia University Medical CenterRecruiting
- Strong Memorial HospitalRecruiting
- Stony Brook University HospitalRecruiting
- SUNY Upstate Medical UniversityRecruiting
- Duke University HospitalRecruiting
- Wake Forest Baptist Medical CenterRecruiting
- University of CincinnatiRecruiting
- OSU East HospitalRecruiting
- OSU Wexner Medical CenterRecruiting
- Mercy St. Vincent Medical CenterRecruiting
- Adventist HealthRecruiting
- Geisinger Medical CenterRecruiting
- UPMC HarrisburgRecruiting
- Hospital of the University of PennsylvaniaRecruiting
- Penn Presbyterian Medical CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- Temple University HospitalRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Guthrie Robert Packer HospitalRecruiting
- Parkland HospitalRecruiting
- Memorial Hermann HospitalRecruiting
- University of Utah HospitalRecruiting
- University of Virginia Medical CenterRecruiting
- VCU Medical CenterRecruiting
- Harborview Medical CenterRecruiting
- Froedtert HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
6 hours - shockable
12 hours - shockable
18 hours - shockable
24 hours - shockable
30 hours - shockable
36 hours - shockable
42 Hours - shockable
48 hours - shockable
60 hours - shockable
72 hours - shockable
6 hours - non shockable
12 hours - non-shockable
18 hours - non-shockable
24 hour - non-shockable
30 hours - non-shockable
36 hours - non-shockable
42 hours - non-shockable
48 hours - non-shockable
60 hours - non-shockable
72 hours - non-shockable
Participants with shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Participants with non-shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.