We propose a study to examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of COPD. The findings should help to provide the basis for determining the use of magnesium in the management of patients presenting to the Emergency Department with Chronic Obstructive Pulmonary Disease).
Conditions
Interventions
Product Name: Magnesium Sulphate
Pharmaceutical Form: Nebuliser solution
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Sponsors
South Devon Health Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · 35 to 80 years old · Diagnosis of COPD as defined by the American Thoracic Society · Presentation to the ED with an acute exacerbation of COPD · FEV1 = 70 % · FEV1 / FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Patients requiring intubation, NIV or too severe to perform spirometry · Arterial pH <7.32 · Clinical history of asthma · Known cardiac disease, chronic renal insufficiency or other serious medical condition · Pregnant women · Clinical or radiographic evidence of pneumonia · Hypotension (systolic blood pressure < 100 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of COPD. The primary outcome measure of the trial is FEV1 (spirometry) (Forced Expiratory Volume in 1 second).;Secondary Objective: The secondary outcome measures of the trial are: FVC (Forced Vital Capacity) Discharge within 48 hrs Risk of requiring NIV or intubation or escalation of treatment Length of hospital stay Arterial blood gas tensions Modified BORG score ;Primary end point(s): FEV1 (Forced expiratory volume in one second) | — |
Countries
United Kingdom
Outcome results
None listed