Trial Outcomes & Findings for MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial) (NCT NCT02856698)
NCT ID: NCT02856698
Last Updated: 2022-06-09
Results Overview
In hospital mortality
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
111 participants
Primary outcome timeframe
28 days after of the hospitalization
Results posted on
2022-06-09
Participant Flow
The recruitment period goes from 08/04/2017 to 30/12/2020
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
|
Overall Study
COMPLETED
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
Baseline characteristics by cohort
| Measure |
Midazolam
n=55 Participants
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
|
Morphine
n=56 Participants
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
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Age, Continuous
|
78.4 years
n=99 Participants
|
79.9 years
n=107 Participants
|
79.15 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 days after of the hospitalizationIn hospital mortality
Outcome measures
| Measure |
Midazolam
n=55 Participants
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
|
Morphine
n=56 Participants
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
|
|---|---|---|
|
In-hospital Mortality
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 1 weekOutcome measures
| Measure |
Midazolam
n=55 Participants
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
|
Morphine
n=56 Participants
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
|
|---|---|---|
|
Number of Participants That Required Invasive Mechanical Ventilation
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 30 daysLength of hospital stay
Outcome measures
| Measure |
Midazolam
n=55 Participants
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
|
Morphine
n=56 Participants
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
|
|---|---|---|
|
Length of Hospital Stay
|
7 days
Interval 5.0 to 14.0
|
6 days
Interval 4.0 to 13.0
|
Adverse Events
Midazolam
Serious events: 10 serious events
Other events: 0 other events
Deaths: 9 deaths
Morphine
Serious events: 24 serious events
Other events: 0 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Midazolam
n=55 participants at risk
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
|
Morphine
n=56 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
ischemic stroke
|
18.2%
10/55 • Number of events 10 • 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).
|
42.9%
24/56 • Number of events 24 • 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).
|
Other adverse events
Adverse event data not reported
Additional Information
Alberto Dominguez Rodriguez. MD, PhD, FESC
Hospital Universitario de Canarias
Phone: +34 922678000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60