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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02498496
Other study ID # MG-1
Secondary ID
Status Withdrawn
Phase Phase 4
First received July 7, 2015
Last updated February 20, 2018
Start date September 2016
Est. completion date November 2017

Study information

Verified date February 2018
Source Hôpital de Verdun
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magnesium Sulfate
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
Placebo
Administration of 100 mL of Normal Saline

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hôpital de Verdun

Outcome

Type Measure Description Time frame Safety issue
Other Respiratory failure requiring intubation Number of patients who require endotracheal intubation 72 hours after randomization
Other Respiratory failure requiring non-invasive ventilation 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 72 hours after randomization
Primary Percentage of Admissions for AECOPD Number of patients admitted to hospital baseline
Secondary Recurrence of AECOPD 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. 10, 30, 90 days after hospital discharge
Secondary 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
Secondary Length of stay Measured in hours, from baseline to discharge, either from ED, or after hospital admission Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.
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