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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02856698
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Alberto Dominguez-Rodriguez, Hospital Universitario de Canarias

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.

Condition or disease Intervention/treatment Phase
Acute Pulmonary Edema Drug: Midazolam Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial
Actual Study Start Date : April 8, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 28 days after of the hospitalization ]
    In hospital mortality after discharge from the hospital


Secondary Outcome Measures :
  1. Mechanical ventilation [ Time Frame: Number of days on ventilator up to 14 days ]
  2. Length of Intensive Care Unit Stay [ Time Frame: 14 days following discharge from care unit stay ]
  3. Length of Hospitalization Stay [ Time Frame: 30 days following discharge from index hospitalization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856698


Contacts
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Contact: Alberto Domínguez, MD,PhD, FESC +34 922678000 adrvdg@hotmail.com

Locations
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Spain
Hospital Universitario Reina Sofía de Córdoba Recruiting
Córdoba, Andalucía, Spain
Principal Investigator: Rafael Calvo-Rodríguez         
Hospital Comarcal de la Axarquía Recruiting
Málaga, Andalucía, Spain
Principal Investigator: Coral Suero-Méndez         
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Cataluña, Spain
Contact: Oscar Miró, MD       omiro@clinic.ub.es   
Contact: Victor Gil, MD       vgil@clinic.cat   
Principal Investigator: Óscar Miró-Andreu         
Sub-Investigator: Víctor Gil-Espinosa         
Hospital Universitario de Canarias Recruiting
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Contact: Guillermo Burillo-Putze, MD, PhD       gburillo@telefonica.net   
Hospital General de Alicante Recruiting
Alicante, Spain
Contact: Pere Llorens, MD, PhD       llorens_ped@gva.es   
Hospital Clínico Universitario San Carlos Recruiting
Madrid, Spain
Principal Investigator: Francisco Javier Martín-Sánchez         
Hospital General Universitario Reina Sofía Recruiting
Murcia, Spain, 30003
Contact: Pascual Piñera Salmerón, MD       pascual.pinera@gmail.com   
Hospital Comarcal de Axarquia Recruiting
Málaga, Spain
Contact: Coral Suero, MD       coralsuero@gmail.com   
Sponsors and Collaborators
Alberto Dominguez-Rodriguez

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Responsible Party: Alberto Dominguez-Rodriguez, Alberto Domínguez- Rodríguez, MD, PhD, FESC, Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT02856698    
Other Study ID Numbers: EUDRACT: 2016-000884-17
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alberto Dominguez-Rodriguez, Hospital Universitario de Canarias:
Acute heart failure
morphine
midazolam
in-hospital mortality
Additional relevant MeSH terms:
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Pulmonary Edema
Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Midazolam
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action