Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-006754
NCT ID: NCT02908308
Sponsor Protocol Number: 17-006754
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 |
|
More information
Publications
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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