MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
Solo gli utenti registrati possono tradurre articoli
Entra registrati
Il collegamento viene salvato negli appunti
StatoReclutamento
Sponsor
Alberto Dominguez-Rodriguez
TEST CLINICO: NCT02856698
BioSeek: NCT02856698
Parole chiave
Astratto
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.
Date
| Ultimo verificato: | 09/30/2019 |
| Primo inviato: | 07/19/2016 |
| Iscrizione stimata inviata: | 08/01/2016 |
| Primo pubblicato: | 08/04/2016 |
| Ultimo aggiornamento inviato: | 10/29/2019 |
| Ultimo aggiornamento pubblicato: | 10/30/2019 |
| Data di inizio effettiva dello studio: | 04/07/2017 |
| Data di completamento primaria stimata: | 12/30/2020 |
| Data stimata di completamento dello studio: | 12/30/2020 |
Condizione o malattia
Acute Pulmonary Edema
Intervento / trattamento
Drug: midazolam
Drug: morphine
Fase
Fase 4
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| 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 |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | 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. |
Risultato
Misure di esito primarie
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
Misure di esito secondarie
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]
