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Study Design and Rationale of “A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema”: MIMO Trial

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Abstract

Purpose

Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial.

Methods

The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length.

Conclusions

In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect—and especially the risk—when using morphine for APE.

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Acknowledgements

Thank you to the following: Ms. Veronica Dominguez-Gonzalez for technical assistance and to Celine of JC OnLine Business Consulting for her linguistic revision of this manuscript.

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Correspondence to Alberto Dominguez-Rodriguez.

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Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Conflict of Interest

The authors declare that they have no conflict of interest.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Funding

This study was funded by a grant from the Facultad de Ciencias de la Salud of the Universidad Europea de Canarias (Project CIPI /082/16).

Additional information

The following are MIMO investigators: Miguel Angel Pinillos-Echeverría (Complejo Hospitalario de Navarra, Servicio de Urgencias, Spain), Miguel Alberto Rizzi (Hospital de la Santa Creu i Sant Pau de Barcelona, Servicio de Urgencias, Spain), Francisco Javier Martin-Sanchez (Hospital Clínico Universitario San Carlos de Madrid, Servicio de Urgencias, Spain), Coral Suero-Mendez (Hospital Comarcal de la Axarquia de Malaga, Servicio de Urgencias, 2 Spain), Rafael Calvo-Rodriguez (Hospital Universitario Reina Sofia de Cordoba, Servicio de Urgencias, Spain), Cesar Carballo-Carmona (Hospital La Paz de Madrid, Servicio de Urgencias, Spain), Victor Gil (Hospital Clinic de Barcelona, Servicio de Urgencias, Spain), Pablo Herrero (Hospital Universitario Central de Asturias, Servicio de Urgencias, Spain), Angel Ascensino Bajo Bajo (Complejo Asistencial Universitario de Salamanca, Servicio de Urgencias, Spain), and Pascual Piñera Salmeron (Hospital General Universitario Reina Sofia de Murcia, Servicio de Urgencias, Spain).

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Dominguez-Rodriguez, A., Burillo-Putze, G., Garcia-Saiz, M.d.M. et al. Study Design and Rationale of “A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema”: MIMO Trial. Cardiovasc Drugs Ther 31, 209–213 (2017). https://doi.org/10.1007/s10557-017-6722-5

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