A multicentre randomized pilot trial on the effectiveness of different levels of cooling in comatose survivors of out-of-hospital cardiac arrest: the FROST-I trial

Esteban Lopez-de-Sa, Miriam Juarez, Eduardo Armada, José C. Sanchez-Salado, Pedro L. Sanchez, Pablo Loma-Osorio, Alessandro Sionis, Maria C. Monedero, Manuel Martinez-Sellés, Juán C. Martín-Benitez, Albert Ariza, Aitor Uribarri, José M. Garcia-Acuña, Patricia Villa, Pablo J. Perez, Christian Storm, Anne Dee, Jose L. Lopez-Sendon

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    Abstract

    © 2018, Springer-Verlag GmbH Germany, part of Springer Nature and ESICM. Purpose: To obtain initial data on the effect of different levels of targeted temperature management (TTM) in out-of-hospital cardiac arrest (OHCA). Methods: We designed a multicentre pilot trial with 1:1:1 randomization to either 32 °C (n = 52), 33 °C (n = 49) or 34 °C (n = 49), via endovascular cooling devices during a 24-h period in comatose survivors of witnessed OHCA and initial shockable rhythm. The primary endpoint was the percentage of subjects surviving with good neurologic outcome defined by a modified Rankin Scale (mRS) score of ≤ 3, blindly assessed at 90 days. Results: At baseline, different proportions of patients who had received defibrillation administered by a bystander were assigned to groups of 32 °C (13.5%), 33 °C (34.7%) and 34 °C (28.6%; p = 0.03). The percentage of patients with an mRS ≤ 3 at 90 days (primary endpoint) was 65.3, 65.9 and 65.9% in patients assigned to 32, 33 and 34 °C, respectively, non-significant (NS). The multivariate Cox proportional hazards model identified two variables significantly related to the primary outcome: male gender and defibrillation by a bystander. Among the 43 patients who died before 90 days, 28 died following withdrawal of life-sustaining therapy, as follows: 7/16 (43.8%), 10/13 (76.9%) and 11/14 (78.6%) of patients assigned to 32, 33 and 34 °C, respectively (trend test p = 0.04). All levels of cooling were well tolerated. Conclusions: There were no statistically significant differences in neurological outcomes among the different levels of TTM. However, future research should explore the efficacy of TTM at 32 °C. Clinical trial registration: ClinicalTrials.gov unique identifier: NCT02035839 (http://clinicaltrials.gov).
    Original languageEnglish
    Pages (from-to)1807-1815
    JournalIntensive Care Medicine
    Volume44
    DOIs
    Publication statusPublished - 1 Nov 2018

    Keywords

    • Brain injury
    • Cardiac arrest
    • Post-cardiac arrest syndrome
    • Resuscitation
    • Sudden death
    • Targeted temperature management

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  • Cite this

    Lopez-de-Sa, E., Juarez, M., Armada, E., Sanchez-Salado, J. C., Sanchez, P. L., Loma-Osorio, P., Sionis, A., Monedero, M. C., Martinez-Sellés, M., Martín-Benitez, J. C., Ariza, A., Uribarri, A., Garcia-Acuña, J. M., Villa, P., Perez, P. J., Storm, C., Dee, A., & Lopez-Sendon, J. L. (2018). A multicentre randomized pilot trial on the effectiveness of different levels of cooling in comatose survivors of out-of-hospital cardiac arrest: the FROST-I trial. Intensive Care Medicine, 44, 1807-1815. https://doi.org/10.1007/s00134-018-5256-z