Study Stopped
The study was stopped because of the adverse events
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
MIMO
Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial
1 other identifier
interventional
111
1 country
8
Brief Summary
Acute pulmonary edema (APE) is a common condition in the emergency room, associated with considerable mortality. The use of intravenous morphine in the treatment of APE remains controversial and Benzodiazepines have been suggested as an alternative for morphine to relieving dyspnoea and anxiety in the patients with APE. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2017
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
April 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
May 19, 2022
CompletedJune 9, 2022
May 1, 2022
3.7 years
July 20, 2016
May 14, 2021
May 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-hospital Mortality
In hospital mortality
28 days after of the hospitalization
Secondary Outcomes (2)
Number of Participants That Required Invasive Mechanical Ventilation
Up to 1 week
Length of Hospital Stay
Up to 30 days
Study Arms (2)
midazolam
EXPERIMENTALThe dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
morphine
ACTIVE COMPARATORThe dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE
Interventions
Eligibility Criteria
You may qualify if:
- Patients with acute pulmonary edema with dyspnoea and anxiety
You may not qualify if:
- Patients with known severe liver disease.
- Patients with known severe renal disease.
- Patients with expectation of death from other illness during the course of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Andalusia, Spain
Hospital Comarcal de la Axarquía
Málaga, Andalusia, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital Comarcal de Axarquia
Málaga, Spain
Hospital General Universitario Reina Sofía
Murcia, 30003, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The main limitation of the study was that the study treatment, because it was a serious pathology, was sometimes administered in the ambulance, before admission to the hospital emergency room. Another limitation has been the COVID-19 pandemic
Results Point of Contact
- Title
- Alberto Dominguez Rodriguez. MD, PhD, FESC
- Organization
- Hospital Universitario de Canarias
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Alberto Domínguez- Rodríguez, MD, PhD, FESC
Study Record Dates
First Submitted
July 20, 2016
First Posted
August 5, 2016
Study Start
April 8, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 9, 2022
Results First Posted
May 19, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share