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

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: Acute Pulmonary Edema
• Intervention / Treatment: Drug: Midazolam; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Hospital General de Alicante
  • Madrid, Spain
    • Hospital Clínico Universitario San Carlos
  • Murcia, Spain, 30003
    • Hospital General Universitario Reina Sofía
  • Málaga, Spain
    • Hospital Comarcal de Axarquia
  • Andalucía
    • Córdoba, Andalucía, Spain
      • Hospital Universitario Reina Sofia de Cordoba
    • Málaga, Andalucía, Spain
      • Hospital Comarcal de la Axarquía
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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		Up to 1 week
Length of Hospital Stay	Length of hospital stay	Up to 30 days

Collaborators and Investigators

• Sponsor: Alberto Dominguez-Rodriguez

Study record dates

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: midazolam; morphine; Acute heart failure; in-hospital mortality
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Morphine
• 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