Clinical Trial: MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Alberto Domínguez Rodríguez

Current Primary Outcome: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 28 days after of the hospitalization ]

In hospital mortality after discharge from the hospital


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mechanical ventilation [ Time Frame: Number of days on ventilator up to 14 days ]
  • Length of Intensive Care Unit Stay [ Time Frame: 14 days following discharge from care unit stay ]
  • Length of Hospitalization Stay [ Time Frame: 30 days following discharge from index hospitalization ]


Original Secondary Outcome: Same as current

Information By: Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Dates:
Date Received: July 20, 2016
Date Started: November 2016
Date Completion: December 2017
Last Updated: August 16, 2016
Last Verified: August 2016