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The study was stopped because of the adverse events
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam | Experimental | The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg. |
|
| morphine | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Dose use according to the product technical sheet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital Mortality | In hospital mortality | 28 days after of the hospitalization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina SofÃa de Córdoba | Córdoba | Andalusia | Spain | |||
| Hospital Comarcal de la AxarquÃa |
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The recruitment period goes from 08/04/2017 to 30/12/2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam | The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg. Midazolam: Dose use according to the product technical sheet |
| FG001 | 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 Morphine: Dose use according to the product technical sheet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All quantitative and categorical variables were expressed as median (interquartile range) and n (%) and were compared using the Mann-Whitney U test and Fisher's exact test respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam | The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg. Midazolam: Dose use according to the product technical sheet |
| BG001 | Morphine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All quantitative and categorical variables were expressed as median (interquartile range) and n (%) and were compared using the Mann-Whitney U test and Fisher's exact test respectively. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | In-hospital Mortality | In hospital mortality | Posted | Count of Participants | Participants | 28 days after of the hospitalization |
|
The adverse events were collected through study completion (1 year)
The adverse events observed were related to the circulatory, respiratory, and other systems (nervous, endocrine and renal).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midazolam | The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg. Midazolam: Dose use according to the product technical sheet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ischemic stroke | Cardiac disorders | Systematic Assessment | Patient with capsular lacunar infarction three days after receiving study treatment for acute lung edema which is the disease under study in the clinical trial |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Dominguez Rodriguez. MD, PhD, FESC | Hospital Universitario de Canarias | +34 922678000 | adrvdg@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2016 | Oct 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2021 | Oct 26, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Morphine |
| Drug |
Dose use according to the product technical sheet |
|
| Málaga |
| Andalusia |
| Spain |
| Hospital ClÃnic 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 ClÃnico Universitario San Carlos | Madrid | Spain |
| Hospital Comarcal de Axarquia | Málaga | Spain |
| Hospital General Universitario Reina SofÃa | Murcia | 30003 | Spain |
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
Morphine: Dose use according to the product technical sheet
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants That Required Invasive Mechanical Ventilation | Posted | Number | participants | Up to 1 week |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay | Posted | Median | Inter-Quartile Range | days | Up to 30 days |
|
|
|
| 9 |
| 55 |
| 10 |
| 55 |
| 0 |
| 55 |
| EG001 | 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 Morphine: Dose use according to the product technical sheet | 13 | 56 | 24 | 56 | 0 | 56 |
|
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| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |