Acute Pulmonary EdemaPhase 4MIMONCT02856698

MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

A Phase 4 study testing Midazolam and Morphine in people with Acute Pulmonary Edema, run by Alberto Dominguez-Rodriguez at 8 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pulmonary Edema
What is being tested?: Midazolam and Morphine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 8 sitesSpain
Study dates: 8 Apr 2017to 31 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with acute pulmonary edema with dyspnoea and anxiety

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Spain8 sites

Hospital General de Alicante
Alicante
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Andalusia
Hospital Clínico Universitario San Carlos
Madrid
Hospital Comarcal de la Axarquía
Málaga, Andalusia
Hospital Comarcal de Axarquia
Málaga
Hospital General Universitario Reina Sofía
Murcia, 30003
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

Other trials in Spain

About this study

Official title: Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial

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.

Conditions: Acute Pulmonary Edema
Being tested: Midazolam, Morphine
Keywords: Acute heart failure, morphine, midazolam, in-hospital mortality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MidazolamDrug
Dose use according to the product technical sheet
MorphineDrug
Dose use according to the product technical sheet

Study groups in NCT02856698
Study group	Role	What they receive
midazolam	Experimental	The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg. Receives: Drug: Midazolam
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 Receives: Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

In-hospital Mortality
In hospital mortality
Measured: 28 days after of the hospitalization

Secondary outcomes (2)

Number of Participants That Required Invasive Mechanical Ventilation
Measured: Up to 1 week
Length of Hospital Stay
Length of hospital stay
Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 201731 Dec 2020

First posted5 Aug 2016 (estimated)
Study start8 Apr 2017
Primary completion31 Dec 2020
Study completion31 Dec 2020

Why it stopped: The study was stopped because of the adverse events

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Pulmonary EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02856698
Sponsor's protocol ID: EUDRACT: 2016-000884-17
Acronym: MIMO
Status last verified: May 2022
First submitted: 20 Jul 2016
Last updated: 9 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Active, not recruitingObservational study
Effect of a Focused Point-of-care Ultrasonography Screening Protocol in Hospitalized Patients
Heart Failure, Congestive, Renal Failure Acute Chronic
Not yet recruiting
Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application
Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema
RecruitingObservational study
MRI Assessment of Pulmonary Edema in Acute Heart Failure
Acute Heart Failure, Pulmonary Edema With Heart Failure

All Acute Pulmonary Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial
ClinicalTrials.gov ID: NCT02856698
Acronym / sponsor ID: MIMO / EUDRACT: 2016-000884-17
Conditions: Acute Pulmonary Edema
Keywords: Acute heart failure, morphine, midazolam, in-hospital mortality
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped because of the adverse events
Enrolment: 111 participants (actual)
Lead sponsor: Alberto Dominguez-RodriguezUniversity, hospital or other
Study start: 8 Apr 2017 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 5 Aug 2016 (estimated)
Results: Posted 19 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
midazolam	Experimental	Drug: MidazolamThe dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
morphine	Active comparator	Drug: MorphineThe 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with acute pulmonary edema with dyspnoea and anxiety

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MidazolamDose use according to the product technical sheet	Drug	midazolam
MorphineDose use according to the product technical sheet	Drug	morphine

Primary outcome

In-hospital Mortality
Time frame: 28 days after of the hospitalization
In hospital mortality

2 secondary outcomes

Number of Participants That Required Invasive Mechanical Ventilation
Time frame: Up to 1 week
Length of Hospital Stay
Time frame: Up to 30 days

Results and safety

Results posted to the registry on 19 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Midazolam	55	48
Morphine	56	46

Primary outcome: In-hospital Mortality

Time frame: 28 days after of the hospitalization. Count of participants. Unit: Participants

Measure	Midazolam n = 55	Morphine n = 56
Value	7	10

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected through study completion (1 year). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Midazolam	10 of 55 (18.2%)	0 of 55 (0%)	9 of 55
Morphine	24 of 56 (42.9%)	0 of 56 (0%)	13 of 56

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Pulmonary Edema

RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Active, not recruitingObservational study
Effect of a Focused Point-of-care Ultrasonography Screening Protocol in Hospitalized Patients
Heart Failure, Congestive, Renal Failure Acute Chronic
Not yet recruiting
Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application
Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema
RecruitingObservational study
MRI Assessment of Pulmonary Edema in Acute Heart Failure
Acute Heart Failure, Pulmonary Edema With Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Midazolam and Morphine in people with Acute Pulmonary Edema, run by Alberto Dominguez-Rodriguez at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital Mortality (time frame: 28 days after of the hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.