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

Withdrawn

• Conditions: 10007521; cardiac arrest; post anoxic coma; 10014623

• Registration Number: NL-OMON53374
• Lead Sponsor: Dept of anaestesia and intensive care, Helsingborg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 270

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 <8) (patients not able to obey verbal commands) after sustained ROSC.

Exclusion Criteria

* Known limitations in care or a Do not resuscitate (DNR)-order
* Known disease making 180 day survival unlikely
* Temperature on admisison <30°C.
* On ECMO prior to ROSC
* Obvious or suspected pregnancy
* Intracranial bleeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to determine if hypothermia (33°C)<br /><br>increases 180 day<br /><br>survival when compared to normothermia and early treatment of fever, in<br /><br>patients who are<br /><br>unconscious after OHCA.</p><br>

Secondary Outcome Measures

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