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

NCT02498496 | Withdrawn Phase 4 DMC

• 1 other identifier: MG-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; AECOPD; Magnesium Sulfate; Acute exacerbation of COPD; Chronic Obstructive Pulmonary Disease; ED; ER; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Percentage of Admissions for AECOPD

  Number of patients admitted to hospital

  baseline

Secondary Outcomes (3)

• Recurrence of AECOPD

  10, 30, 90 days after hospital discharge

• 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.

Other Outcomes (2)

• Respiratory failure requiring intubation

  72 hours after randomization

• Respiratory failure requiring non-invasive ventilation

  72 hours after randomization

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.

Drug: Magnesium Sulfate

Placebo

PLACEBO COMPARATOR

Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.

Drug: Placebo

Interventions

Magnesium Sulfate DRUG

Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.

Also known as: Magnesium Sulfate Injection 50% Baxter. Number 5430

Magnesium Sulfate

Placebo DRUG

Administration of 100 mL of Normal Saline

Also known as: Normal saline 0.9 % Baxter 50 mL.

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or previous smoking for at least 10 pack-years
• Confirmed COPD :
• reported by the patient if already diagnosed in the past by a pulmonary disease specialist or on the basis of respiratory function tests; or
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital de Verdun: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emergencies

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ivan Pavlov, MD

  Hôpital de Verdun

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Physician

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 15, 2015
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02