TrialReader

Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease

NCT02498496 — Phase 4, Withdrawn, Hôpital de Verdun
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

MASTER-ED : Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Seen in the Emergency Department

RegistryNCT02498496
StatusWithdrawn - financing delays
PhasePhase 4
Study typeInterventional; randomized, single group, masking: quadruple, treatment
SponsorHôpital de Verdun (Other)
ConditionsPulmonary Disease, Chronic Obstructive
InterventionsMagnesium Sulfate, Placebo (Drug)
Datesstart 2016-09-01, primary completion 2017-10-01 (estimated), completion 2017-11-01 (estimated), first posted 2015-07-15, last updated 2018-02-22

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Pulmonary Disease, Chronic Obstructive All trials of Magnesium Sulfate All trials of Placebo

-Summary

The purpose of this study is to assess whether administration of a bolus dose of MgSO4 (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the management of Acute Exacerbations of Chronic Pulmonary Obstructive Disease (AECOPD) in the emergency department. The investigators hypothesize that MgSO4 causes faster recovery of the bronchospasm, and a reduction of the dead space, translating to the following clinical outcomes : less hospitalisation, lower length of stay (LOS), better composite outcome of hospitalisation + LOS + readmission for AECOPD.

Expand all sections  ·  Collapse all

+Detailed description

Patients presenting to the participant Emergency Departments (ED) with a diagnosis of AECOPD and who receive at least one dose of albuterol, will be randomized to receive either placebo or one dose of MgSO4 2g IV. Security and efficacy outcomes will be measured.

+Arms and interventions

ArmTypeInterventionsDescription
Magnesium SulfateExperimentalDrug: Magnesium SulfateAdministration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.
PlaceboPlacebo comparatorDrug: PlaceboAdministration of a bolus dose of 100 mL of Normal Saline, in 20 min.
  • Magnesium Sulfate (Drug), also known as Magnesium Sulfate Injection 50% Baxter. Number 5430: Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
  • Placebo (Drug), also known as Normal saline 0.9 % Baxter 50 mL.: Administration of 100 mL of Normal Saline

+Outcome measures

Primary outcomes

  • Percentage of Admissions for AECOPD [baseline]: Number of patients admitted to hospital

Secondary outcomes

  • Recurrence of AECOPD [10, 30, 90 days after hospital discharge]: A composite outcome of (death, re-admission for AECOPD, new visit for AECOPD in the ED) in patients who are discharged either directly from the ED or after admission on the wards.
  • Mortality of any cause [Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and for 30 days after discharge, up to 1 year after randomization]
  • Length of stay [Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.]: Measured in hours, from baseline to discharge, either from ED, or after hospital admission

Other outcomes

  • Respiratory failure requiring intubation [72 hours after randomization]: Number of patients who require endotracheal intubation
  • Respiratory failure requiring non-invasive ventilation [72 hours after randomization]: Number of patients who require non-invasive ventilation (CPAP, bilevel positive airway pressure (BiPAP) , Optiflow), excluding patients who were using non-invasive ventilation before baseline

+Eligibility

Sex: All, ages: 35 Years to any

Inclusion Criteria:

* Current or previous smoking for at least 10 pack-years
* Confirmed COPD :

  1. reported by the patient if already diagnosed in the past by a pulmonary disease specialist or on the basis of respiratory function tests; or
  2. new diagnosis in the ED, with confirmatory pulmonary tests showing Forced Expiratory Volume (FEV1) / Forced Vital Capacity (FVC) ratio < 70% and FEV1< 80%
* Patient requires at least one dose of albuterol (salbutamol).

Exclusion Criteria:

* Dialysis patients
* Severe kidney disease, known or suspected to have a creatine clearance < 15.
* Metastatic neoplasm
* Patients who received IV MgSO4 in the last week.
* Hypotension, defined as systolic blood pressure less than 90.

+Investigators

My Notes