Newsletter August 28th 2025
Dear STEPCARE team,
We hope that everyone on the summer side of Earth have had some peaceful summer weeks, and that the southern hemisphere is looking forward to spring season! Looking at the recruitment numbers it seems busy in the ICUs. We passed 2000 in July and next milestone is already 2200 participants. Incredible work from all sites!
Interim analysis
The second interim analysis has been reviewed by the data safety monitoring committee and their recommendation is that STEPCARE should continue without any changes. The DSMC congratulates to the progress and have asked for a third and probably last interim analysis now before the home stretch to 3500 participants, which we likely will reach within a year. Therefore, we ask all sites to meticulously update the eCRFs and 30-day outcome for all participants randomized before July 8th. Please, also update as much of the 6-month outcome as possible. The last date for data entry for the third interim is September 30th (five weeks from now).
New sites
It is very rewarding to be part of the STEPCARE initiative and see the willingness from everyone to contribute to this robust trial. Currently we are working with some few last sites to start recruitment and we congratulate those who have started since the last newsletter.
Sub-studies
We have plenty of sub-studies ongoing. We have also prepared eCRF addition for several of these. With 1300 patients more to go we can still make those sub-studies that need prospective data collection happen at new sites. The responsibility of the sub-studies are the PI of the corresponding studies. In order to facilitate and connect STEPCARE researchers we will arrange for 2 Zoom events on September 10th and 24th at 2-4 PM CEST. If you are running a sub-study and feel that you need more sites please come and present at one of these sessions.
If you have missed it all of our protocol main papers and the protocol paper for the Extended Follow-up have all been published in Acta Aaesthesiologica Scandinavica.
Finally, are you planning to attend the ESICM meeting in Munich? If so email markus.skrifvars@hus.fi ASAP. If we have STEPCARE investigators present we will arrange for a meeting and a possible dinner.