Methodology Score: 2.5/5
Usefulness Score: 2/5
Schortgen F, et al. Am J Respir Crit Care Med. 2012 May 15;185(10):1088-95
This randomized, non-blinded trial found in an ICU population that external cooling in febrile patients with septic shock resulted in a 50% decrease in vasopressor requirements at 12 and 24 hours, however, their data was underwhelming as their primary outcome at 48 hours was non-significant. The authors attempted to emphasize a decrease in mortality, however their study was not powered to appropriately address this. The idea of fever control in septic shock is an interesting one, but this study leaves us wanting further research, specifically a randomized trial comparing external cooling and antipyretics powered to show a mortality difference.
By: Dr. Shahbaz Syed
(Presented March 2014)
Prior to conducting a randomized controlled trial, it is important for investigators to determine whether or not there is clinical equipoise about the study question. i.e. are clinicians truly uncertain regarding the risk/benefit of the proposed intervention? If the answer is no, it may be unethical to conduct the trial but further, it may lead to selection bias during trial enrolment if clinicians strongly feel that a given intervention has either clear benefit or clear harm – they will not want their patients enrolled and these patients may be systematically different from those who are enrolled.
By: Lisa Calder