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Targeted hypothermia vs. targeted normothermia after out-of-hospital cardiac arrest, a randomised clinical trial

Targeted hypothermia vs. targeted normothermia after out-of-hospital cardiac arrest, a randomised clinical trial - TTM 2

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53374
Enrollment
270
Registered
2017-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac arrest post anoxic coma

Interventions

The intervention period will commence at the time of randomisation. Rapid cooling in the hypothermia group will be achieved by means of cold fluids and state-of-the-art cooling devices (intravascula
cardia arrest
hypothermia
neuroprotection

Sponsors

Dept of anaestesia and intensive care, Helsingborg Hospital
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 years, 2) Out of hospital cardiac arrest of presumed cardiac cause, 3) Sustained return of sponteneous circulation (ROSC), 4) Unconsciousness (GCS

Exclusion criteria

Exclusion criteria: * Known limitations in care or a Do not resuscitate (DNR)-order * Known disease making 180 day survival unlikely * Temperature on admisison

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to determine if hypothermia (33°C) increases 180 day survival when compared to normothermia and early treatment of fever, in patients who are unconscious after OHCA.

Secondary

MeasureTime frame
To evaluate if there is any difference in functional outcomes, using the Glasgow Outcome Scale-extended (GOS-E) between patients managed at 33°C compared to normothermia and early treatment of fever. GOS-E will be assessed at 180 days and at 24 months. * To evaluate potential differences in health-related quality of life (HRQoL) at follow up using EQ5D-5L at 180 days and at 24 months. * Time-to-event (survival). All patients will be followed until the last included patient has been followed-up at 180 days. If death has not occurred patients will be censored at this point.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)