MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial) (MIMO)

May 20, 2022 updated by: Alberto Dominguez-Rodriguez

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General de Alicante
      • Madrid, Spain
        • Hospital Clinico Universitario San Carlos
      • Murcia, Spain, 30003
        • Hospital General Universitario Reina Sofia
      • Málaga, Spain
        • Hospital Comarcal de Axarquia
    • Andalucía
      • Córdoba, Andalucía, Spain
        • Hospital Universitario Reina Sofía de Córdoba
      • Málaga, Andalucía, Spain
        • Hospital Comarcal de la Axarquia
    • Cataluña
      • Barcelona, Cataluña, Spain
        • Hospital Clinic i Provincial de Barcelona
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute pulmonary edema with dyspnoea and anxiety

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: midazolam
The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
Drug: Midazolam
Dose use according to the product technical sheet
Active Comparator: morphine
The 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
Drug: Morphine
Dose use according to the product technical sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Mortality
Time Frame: 28 days after of the hospitalization
In hospital mortality
28 days after of the hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Required Invasive Mechanical Ventilation
Time Frame: Up to 1 week
Up to 1 week
Length of Hospital Stay
Time Frame: Up to 30 days
Length of hospital stay
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberto Dominguez-Rodriguez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT: 2016-000884-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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