Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest

Overview

About this study

ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Out-of-hospital cardiac arrest
Presumed cardiac cause of cardiac arrest
Unconscious with a FOUR-score
Stable return of spontaneous circulation (20 min)
Eligible for intensive care treatment without restrictions

Exclusion Criteria:

Pregnancy (confirmed or suspected)
Intracerebral haemorrhage
Initial temperature <30°C
On ECMO prior to ROSC
Known disease making 180 day-survival unlikely
More than 180 minutes from ROSC

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Jennifer Fugate, D.O.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Jennifer Fugate, D.O.

Closed for enrollment

More information

Publications

Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function. Therapeutic hypothermia is recommended by international guidelines, but the supporting evidence is limited, and the target temperature associated with the best outcome is unknown. Our objective was to compare two target temperatures, both intended to prevent fever. Read More on PubMed

Clinical Trials