Back to resultsMIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial) (MIMO)
Primary Purpose
Acute Pulmonary Edema
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Midazolam
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pulmonary Edema focused on measuring Acute heart failure, morphine, midazolam, in-hospital mortality
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Reina Sofía de Córdoba
- Hospital Comarcal de la Axarquía
- Hospital Clínic i Provincial de Barcelona
- Hospital Universitario de Canarias
- Hospital General de Alicante
- Hospital Clínico Universitario San Carlos
- Hospital General Universitario Reina Sofía
- Hospital Comarcal de Axarquia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
midazolam
morphine
Arm Description
The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
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
Outcomes
Primary Outcome Measures
In-hospital Mortality
In hospital mortality
Secondary Outcome Measures
Number of Participants That Required Invasive Mechanical Ventilation
Length of Hospital Stay
Length of hospital stay
Full Information
NCT ID
NCT02856698
First Posted
July 20, 2016
Last Updated
May 20, 2022
Sponsor
Alberto Dominguez-Rodriguez
1. Study Identification
Unique Protocol Identification Number
NCT02856698
Brief Title
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
Acronym
MIMO
Official Title
Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped because of the adverse events
Study Start Date
April 8, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alberto Dominguez-Rodriguez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pulmonary Edema
Keywords
Acute heart failure, morphine, midazolam, in-hospital mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
midazolam
Arm Type
Experimental
Arm Description
The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
Arm Title
morphine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Dose use according to the product technical sheet
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Dose use according to the product technical sheet
Primary Outcome Measure Information:
Title
In-hospital Mortality
Description
In hospital mortality
Time Frame
28 days after of the hospitalization
Secondary Outcome Measure Information:
Title
Number of Participants That Required Invasive Mechanical Ventilation
Time Frame
Up to 1 week
Title
Length of Hospital Stay
Description
Length of hospital stay
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario Reina Sofía de Córdoba
City
Córdoba
State/Province
Andalucía
Country
Spain
Facility Name
Hospital Comarcal de la Axarquía
City
Málaga
State/Province
Andalucía
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Clínico Universitario San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital General Universitario Reina Sofía
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Facility Name
Hospital Comarcal de Axarquia
City
Málaga
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
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