Abstract
Background and Aims
In a recent high-quality randomised controlled trial (RCT), strict therapeutic normothermia
(STN) following cardiac arrest with coma resulted in similar outcomes to therapeutic
hypothermia (TH). We aimed to test the feasibility, reproducibility, and safety of
the STN protocol outside of its RCT context.
Methods
In two teaching hospital ICUs, we performed a before-and-after study comparing the
previously International Liaison Committee on Resuscitation (ILCOR)-endorsed TH protocol
to the recently studied STN protocol. The primary feasibility end point was the percentage
of temperature recordings in the prescribed range in the first 24 h of treatment. Secondary end points included pharmacological management and complications.
Results
We studied 69 similar patients in each group. We found no difference in feasibility
as shown by the proportion of within range temperatures. However, the median doses
of midazolam (37 mg vs. 9 mg, p = 0.02), fentanyl (883 μg vs. 310 μg, p = 0.01) and the use of muscle relaxants (84.1% vs. 59.4%, p = 0.001) was greater with the TH protocol. Furthermore, shivering (52.2% vs. 18.8%,
p < 0.001), a composite of other pre-defined complications (66.7% vs. 47.8%, p < 0.03) and fever in the first 96 h (55.1% vs. 33.3%, p = 0.01) were also more common with the TH protocol.
Conclusions
The STN protocol was successfully reproduced outside of an RCT and appeared associated
with fewer complications than the TH protocol. Our findings imply that the STN protocol
may offer clinical advantages over the TH protocol.
Keywords
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Article info
Publication history
Published online: June 24, 2016
Accepted:
June 15,
2016
Received in revised form:
April 15,
2016
Received:
January 27,
2016
Identification
Copyright
© 2016 Elsevier Ireland Ltd. All rights reserved.
