Name: Influence of Cooling duration on Efficacy in Cardiac Arrest Patients
Contact: Dr. John Burno (PI) and Magali Jorand-Fletch (Lead CRC) (352) 294-5391
Enrolling hours: Enrollment to begin soon
Study Sponsor: NIH-NINDS
Study Design: Randomized, response-adaptive, duration/dose finding, comparative effectiveness
clinical trial with blinded outcome assessment
Sites: About 50 hospitals
Primary Study Objectives:
To characterize the duration response curve for hypothermia and determine in each of two populations:
- the shortest duration of cooling that provides the maximal treatment effect, and
- whether the duration-response implies efficacy versus no cooling
Secondary Study Objectives:
- to characterize safety of varying durations of cooling,
- to characterize the effect on neuropsychological outcomes,
- to characterize the effect on patient reported quality of life.
Inclusion:
- 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
Exclusion:
- 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