MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
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StatusMerekrut
Sponsor
Alberto Dominguez-Rodriguez
UJI KLINIS: NCT02856698
BioSeek: NCT02856698
Kata kunci
Abstrak
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.
tanggal
| Terakhir Diverifikasi: | 09/30/2019 |
| Pertama Dikirim: | 07/19/2016 |
| Perkiraan Pendaftaran Telah Dikirim: | 08/01/2016 |
| Pertama Diposting: | 08/04/2016 |
| Pembaruan Terakhir Dikirim: | 10/29/2019 |
| Pembaruan Terakhir Diposting: | 10/30/2019 |
| Tanggal Mulai Studi Sebenarnya: | 04/07/2017 |
| Perkiraan Tanggal Penyelesaian Utama: | 12/30/2020 |
| Perkiraan Tanggal Penyelesaian Studi: | 12/30/2020 |
Kondisi atau penyakit
Acute Pulmonary Edema
Intervensi / pengobatan
Drug: midazolam
Drug: morphine
Tahap
Tahap 4
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| Experimental: midazolam The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg. | Drug: midazolam Dose use according to the product technical sheet |
| Active Comparator: 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 | Drug: morphine Dose use according to the product technical sheet |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
| Jenis Kelamin yang Layak untuk Belajar | All |
| Menerima Relawan Sehat | Iya |
| Kriteria | 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. |
Hasil
Ukuran Hasil Utama
1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [28 days after of the hospitalization]
In hospital mortality after discharge from the hospital
Ukuran Hasil Sekunder
1. Mechanical ventilation [Number of days on ventilator up to 14 days]
2. Length of Intensive Care Unit Stay [14 days following discharge from care unit stay]
3. Length of Hospitalization Stay [30 days following discharge from index hospitalization]
