Prehospital high-dose methylprednisolone in resuscitated out-of-hospital cardiac arrest patients (STEROHCA): a randomized clinical trial
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Patients who are successfully resuscitated following out-of-hospital cardiac arrest (OHCA) are still at a high risk of neurological damage and death. Inflammation and brain injury are components of the post-cardiac arrest syndrome, and can be assessed by systemic interleukin 6 (IL-6) and neuron-specific enolase (NSE). Anti-inflammatory treatment with methylprednisolone may dampen inflammation, thereby improving outcome. This study aimed to determine if prehospital high-dose methylprednisolone could reduce IL-6 and NSE in comatose OHCA patients.
Methods
The STEROHCA trial was a randomized, blinded, placebo-controlled, phase II prehospital trial performed at two cardiac arrest centers in Denmark. Resuscitated comatose patients with suspected cardiac etiology were randomly assigned 1:1 to a single intravenous injection of 250 mg methylprednisolone or placebo. The co-primary outcome was reduction of IL-6 and NSE-blood levels measured daily for 72 h from admission. The main secondary outcome was survival at 180 days follow-up.
Results
We randomized 137 patients to methylprednisolone (n = 68) or placebo (n = 69). We found reduced IL-6 levels (p < 0.0001) in the intervention group, with median (interquartile range, IQR) levels at 24 h of 2.1 pg/ml (1.0; 7.1) and 30.7 pg/ml (14.2; 59) in the placebo group. We observed no difference between groups in NSE levels (p = 0.22), with levels at 48 h of 18.8 ug/L (14.4; 24.6) and 14.8 ug/L (11.2; 19.4) in the intervention and placebo group, respectively. In the intervention group, 51 (75%) patients survived and 44 (64%) in the placebo group.
Conclusion
Prehospital treatment with high-dose methylprednisolone to resuscitated comatose OHCA patients, resulted in reduced IL-6 levels after 24 h, but did not reduce NSE levels.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Intensive Care Medicine |
| Vol/bind | 49 |
| Udgave nummer | 12 |
| Sider (fra-til) | 1467-1478 |
| Antal sider | 12 |
| ISSN | 0342-4642 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
Open access funding provided by Royal Library, Copenhagen University Library. The study was supported by funding from Novo Nordisk Foundation (NNF20OC0064043), and the Research Foundation of Rigshospitalet (E-22652-04). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the manuscript.
Funding Information:
All authors contributed to the critical revision and writing of the publication, and for the final approval to submit including accountability for the accuracy and integrity of the publication. LERO, SW, FF, JEM, JK, and CH contributed to the concept and design of the study. LERO and CH were responsible for the writing of the original draft and the decision to submit for publication, and were responsible for funding acquisition. LERO, RPB, and CH served as project administrators and were accountable for all visualisation in the study. LERO, RPB, MASM, and FTS were responsible for data curation. LERO, RPB, MASM, JG, BN, JJ, TM, ADM, FF, JEM, and JK were a part of the investigation process. LERO, RPB, MASM, JG, BN, JJ, MB, RFS, FF, JEM, JK, and CH provided study materials, and managed laboratory samples and analysis tools throughout the study. Formal analyses were done by LERO, RPB, MB, and RFS. Further, LERO, TM, ADM, FF, JEM, JK, and CH provided supervision during the study. Finally, validation was done by LERO, RPB, SW, FF, JEM, JK, and CH.
Funding Information:
We would like to thank all prehospital physicians and trial guardians who were a part of the inclusion process, in particular daily leaders of the physician manned critical care units: Søren Loumann Nielsen, Steen Møiniche, Henrik Alstrøm, Lars Dahlgaard Hove, and Søren Hestad. Further, we thank Charlotte Barfod and Freddy Lippert from the Emergency Medical Services of the Capital Region of Denmark; Lia Bang from the Department of Cardiology, Rigshospitalet; and Christian Svane from the Trauma Center at Rigshospitalet, all Denmark. We thank all personnel at the Department of Cardiology—especially the Cardiac Intensive Care Unit—at Rigshospitalet, the Intensive Care Unit, Gentofte Hospital, and the Emergency Medical Services of the Capital Region of Denmark, all Copenhagen, Denmark. Further, we thank Mie Christa Larsen, Áslaug Karlsdóttir, and Lesli Hingstrup Larsen from the Clinical Research Unit, Rigshospitalet; Ann Kristine Thorsteinsson, Tung Thanh Phan, and Mette Krefeld Bentzen from the Department of Biochemistry, Rigshospitalet; and staff at the pharmacy of the Capital Region of Denmark, both Copenhagen, Denmark. Finally, we thank Pia Hornbeck from the Medical/Steno Aarhus Research Lab, Aarhus University for technical assistance.
Publisher Copyright:
© 2023, The Author(s).
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