NCT02856698: MIMO

MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Terminated Phase 4 Results posted Last updated 9 June 2022

What this trial tests

Phase 4 trial testing Midazolam in Acute Pulmonary Edema in 111 participants. Terminated before completion.

Timeline

8 April 2017

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Alberto Dominguez-Rodriguez
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	111
Start date	8 April 2017
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	8 locations across Spain

Drugs / interventions tested

• Midazolam (midazolam) — full drug profile →
• Morphine

Conditions studied

• Acute Pulmonary Edema — all drugs for Acute Pulmonary Edema →

Sponsor

Alberto Dominguez-Rodriguez

Who can join

18 and older, any sex, with Acute Pulmonary Edema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

In-hospital Mortality Primary · 28 days after of the hospitalization

In hospital mortality

Group	Value	95% CI
Midazolam	7
Morphine	10

Number of Participants That Required Invasive Mechanical Ventilation Secondary · Up to 1 week

Group	Value	95% CI
Midazolam	3
Morphine	1

Length of Hospital Stay Secondary · Up to 30 days

Length of hospital stay

Group	Value	95% CI
Midazolam	7	5 – 14
Morphine	6	4 – 13

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse events were collected through study completion (1 year). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Midazolam

Serious: 10/55 (18%)

Deaths: 9/55

Morphine

Serious: 24/56 (43%)

Deaths: 13/56

Serious adverse events (1 terms)

Reaction	System	Midazolam	Morphine
ischemic stroke	Cardiac disorders	—	—

Most-reported serious reactions: ischemic stroke.

Data from ClinicalTrials.gov NCT02856698 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Palliative Care in Acute Heart Failure.
   Beattie JM, Higginson IJ, McDonagh TA. · · 2020 · cited 10× · PMID 33123954 · DOI 10.1007/s11897-020-00494-8