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

Completed · Not applicable

Conditions studied: Out-of-hospital Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT02908308

Run by

Helsingborgs Hospital

People needed

1900

Starts

2017-11-18

Expected to finish

2022-12-31

Last updated by the study team

2023-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Out-of-hospital cardiac arrest
• Presumed cardiac cause of cardiac arrest
• Unconscious with a FOUR-score <M4 (not obeying verbal commands)
• Stable return of spontaneous circulation (20 min)
• Eligible for intensive care treatment without restrictions
• Inclusion within 180 minutes of ROSC

You may not qualify if…

• Unwitnessed cardiac arrest with an initial rhythm of asystole
• Temperature on admission <30°C.
• On ECMO prior to ROSC
• Obvious or suspected pregnancy
• Intracranial bleeding
• On ECMO prior to ROSC
• Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy

Where it is running

• UPMC-Presbyterian — Pittsburgh, Pennsylvania, United States
• John Hunter Hospital — Newcastle, New South Wales, Australia
• Concord Repatriation General Hospital — Sydney, New South Wales, Australia
• Liverpool Hospital — Sydney, New South Wales, Australia
• St Vincent's Hospital — Sydney, New South Wales, Australia
• Princess Alexandra Hospital — Brisbane, Queensland, Australia
• Northern Hospital — Epping, Victoria, Australia
• The Alfred — Melbourne, Victoria, Australia
• Austin Hospital — Melbourne, Australia
• Nepean Hospital — Sydney, Australia
• Royal North Shore Hospital — Sydney, Australia
• Innsbruck University Hospital — Innsbruck, Austria
• Erasme Hospital — Brussels, Belgium
• Ziekenhuis Oost-Limburg — Genk, Belgium
• Hradec Kralove Hospital — Hradec Králové, Czechia
• Liberec Hospital — Liberec, Czechia
• General University Hospital — Prague, Czechia
• Aarhus University Hospital — Aarhus, Denmark
• Chu Dupuytren — Limoges, France
• CHU Nantes — Nantes, France
• Cochin University Hospital — Paris, France
• Lariboisière Hospital — Paris, France
• Versailles Hospital — Versailles, France
• Charité, Campus Virchow — Berlin, Germany
• Mayo Clinic Hospital-St. Mary's Campus — Rochester, New York, United States

Full record on ClinicalTrials.gov

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