drugset / Trial / NCT04624776
Steroid Treatment After Resuscitated Out-of-Hospital Cardiac Arrest
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Comatose patients resuscitated from Out-of-Hospital Cardiac Arrest (OHCA) often develop a complicated systemic inflammatory response and have a poor prognosis with neurological damage being the most common cause of death. This study will investigate the anti-inflammatory and neuroprotective effect of early treatment with the glucocorticoid methylprednisolone measured by interleukin-6 and neuron-specific enolase levels in resuscitated comatose OHCA-patients.
Timeline
- Start
- 2020-10-10
- Primary completion
- 2022-07-15
- Completion
- 2023-02-28
Publications
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- Background Stammet P, Collignon O, Hassager C, Wise MP, Hovdenes J, Aneman A, Horn J, Devaux Y, Erlinge D, Kjaergaard J, Gasche Y, Wanscher M, Cronberg T, Friberg H, Wetterslev J, Pellis T, Kuiper M, Gilson G, Nielsen N; TTM-Trial Investigators. Neuron-Specific Enolase as a Predictor of Death or Poor Neurological Outcome After Out-of-Hospital Cardiac Arrest and Targeted Temperature Management at 33 degrees C and 36 degrees C. J Am Coll Cardiol. 2015 May 19;65(19):2104-14. doi: 10.1016/j.jacc.2015.03.538.
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- Background Vasheghani-Farahani A, Sahraian MA, Darabi L, Aghsaie A, Minagar A. Incidence of various cardiac arrhythmias and conduction disturbances due to high dose intravenous methylprednisolone in patients with multiple sclerosis. J Neurol Sci. 2011 Oct 15;309(1-2):75-8. doi: 10.1016/j.jns.2011.07.018. Epub 2011 Aug 9.
- Background Altunbas G, Sucu M, Zengin O. Ventricular repolarization disturbances after high dose intravenous methylprednisolone Theraphy. J Electrocardiol. 2018 Jan-Feb;51(1):140-144. doi: 10.1016/j.jelectrocard.2017.07.017. Epub 2017 Aug 1.
- Background Morrison LJ, Visentin LM, Kiss A, Theriault R, Eby D, Vermeulen M, Sherbino J, Verbeek PR; TOR Investigators. Validation of a rule for termination of resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2006 Aug 3;355(5):478-87. doi: 10.1056/NEJMoa052620.
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- Obling LER, Beske RP, Meyer MAS, Grand J, Wiberg S, Damm-Hejmdal A, Bjerre M, Frikke-Schmidt R, Folke F, Moller JE, Kjaergaard J, Hassager C. Inflammatory response after prehospital high-dose glucocorticoid to patients resuscitated from out-of-hospital cardiac arrest: A sub-study of the STEROHCA trial. Resuscitation. 2024 Sep;202:110340. doi: 10.1016/j.resuscitation.2024.110340. Epub 2024 Jul 31.
- Obling LER, Beske RP, Meyer MAS, Grand J, Wiberg S, Mohr T, Damm-Hejmdal A, Forman JL, Frikke-Schmidt R, Folke F, Moller JE, Kjaergaard J, Hassager C. Effect of prehospital high-dose glucocorticoid on hemodynamics in patients resuscitated from out-of-hospital cardiac arrest: a sub-study of the STEROHCA trial. Crit Care. 2024 Jan 22;28(1):28. doi: 10.1186/s13054-024-04808-3.
- Obling LER, Beske RP, Meyer MAS, Grand J, Wiberg S, Nyholm B, Josiassen J, Sondergaard FT, Mohr T, Damm-Hejmdal A, Bjerre M, Frikke-Schmidt R, Folke F, Moller JE, Kjaergaard J, Hassager C. Prehospital high-dose methylprednisolone in resuscitated out-of-hospital cardiac arrest patients (STEROHCA): a randomized clinical trial. Intensive Care Med. 2023 Dec;49(12):1467-1478. doi: 10.1007/s00134-023-07247-w. Epub 2023 Nov 9.
- Obling LER, Beske RP, Wiberg S, Folke F, Moeller JE, Kjaergaard J, Hassager C. Steroid treatment as anti-inflammatory and neuroprotective agent following out-of-hospital cardiac arrest: a randomized clinical trial. Trials. 2022 Nov 22;23(1):952. doi: 10.1186/s13063-022-06838-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 250 mg | Intravenous |