Acute Pulmonary Edema
Conditions
Keywords
Acute heart failure, morphine, midazolam, in-hospital mortality
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.
Interventions
DRUGMidazolam
Dose use according to the product technical sheet
DRUGMorphine
Dose use according to the product technical sheet
Sponsors
Alberto Dominguez-Rodriguez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Mortality | 28 days after of the hospitalization | In hospital mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Required Invasive Mechanical Ventilation | Up to 1 week | — |
| Length of Hospital Stay | Up to 30 days | Length of hospital stay |
Countries
Spain
Participant flow
Recruitment details
The recruitment period goes from 08/04/2017 to 30/12/2020
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| 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 | 56 |
| Total | 111 |
Baseline characteristics
| Characteristic | Midazolam | Morphine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 49 Participants | 95 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Continuous | 78.4 years | 79.9 years | 79.15 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 55 Participants | 56 Participants | 111 Participants |
| Sex: Female, Male Female | 28 Participants | 30 Participants | 58 Participants |
| Sex: Female, Male Male | 27 Participants | 26 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 55 | 13 / 56 |
| other Total, other adverse events | 0 / 55 | 0 / 56 |
| serious Total, serious adverse events | 10 / 55 | 24 / 56 |
Outcome results
Primary
In-hospital Mortality
In hospital mortality
Time frame: 28 days after of the hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam | In-hospital Mortality | 7 Participants |
| Morphine | In-hospital Mortality | 10 Participants |
Secondary
Length of Hospital Stay
Length of hospital stay
Time frame: Up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam | Length of Hospital Stay | 7 days |
| Morphine | Length of Hospital Stay | 6 days |
Secondary
Number of Participants That Required Invasive Mechanical Ventilation
Time frame: Up to 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Midazolam | Number of Participants That Required Invasive Mechanical Ventilation | 3 participants |
| Morphine | Number of Participants That Required Invasive Mechanical Ventilation | 1 participants |