MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Phase 4

Terminated

• Conditions: Acute Pulmonary Edema
• Interventions: Drug: Midazolam; Drug: Morphine

• Registration Number: NCT02856698
• Lead Sponsor: Alberto Dominguez-Rodriguez

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Study Start: 2017-04-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Results First Submitted: 2021-05-14
• Results First Submitted QC: 2022-03-03
• Status Verified: 2022-05
• Results First Posted: 2022-05-19
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam	Midazolam	The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
morphine	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

Primary Outcome Measures

Name	Time	Method
In-hospital Mortality	28 days after of the hospitalization	In hospital mortality

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Up to 30 days	Length of hospital stay
Number of Participants That Required Invasive Mechanical Ventilation	Up to 1 week

Trial Locations

Locations (8)

Hospital Clínico Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Comarcal de la Axarquía; 🇪🇸 Málaga, Andalucía, Spain

Hospital Comarcal de Axarquia; 🇪🇸 Málaga, Spain

Hospital Universitario Reina Sofía de Córdoba; 🇪🇸 Córdoba, Andalucía, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Santa Cruz De Tenerife, Spain

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Hospital General Universitario Reina Sofía; 🇪🇸 Murcia, Spain