MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Acute Pulmonary Edema Clinical Trial

— MIMO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02856698
• Other study ID #: EUDRACT: 2016-000884-17
• Status: Terminated
• Phase: Phase 4
• Start date: April 8, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2022
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pulmonary Edema
• Edema
• Pulmonary Edema

Intervention

Drug:
• Midazolam
Dose use according to the product technical sheet
• Morphine
Dose use according to the product technical sheet

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital Universitario Reina Sofía de Córdoba	Córdoba	Andalucía
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Hospital Comarcal de Axarquia	Málaga
Spain	Hospital Comarcal de la Axarquía	Málaga	Andalucía
Spain	Hospital General Universitario Reina Sofía	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Alberto Dominguez-Rodriguez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital Mortality	In hospital mortality	28 days after of the hospitalization
Secondary	Number of Participants That Required Invasive Mechanical Ventilation		Up to 1 week
Secondary	Length of Hospital Stay	Length of hospital stay	Up to 30 days