Recipient organisationUniversity of SheffieldSource-published name: The University of Sheffield
Funding£1.7M
PeriodSept 2007 — Dec 2012
In plain English
AI plain-English summary
Around 1,200 adults with acute severe asthma will be randomly assigned to receive intravenous magnesium sulphate, nebulised magnesium sulphate, or standard therapy in a head-to-head trial to settle a long-running clinical debate. Magnesium sulphate is already used in some emergency departments for severe asthma attacks, but doctors disagree on whether it should be given as a first-line treatment and whether the intravenous or nebulised route works better. Current guidelines are inconsistent, leaving clinicians without clear evidence on which approach reduces hospital admissions and relieves breathlessness most effectively. If the trial shows that either form of magnesium sulphate outperforms standard care, it could change emergency treatment protocols across the NHS. Patients might avoid hospital admission altogether, reducing pressure on already crowded wards and intensive care units. The economic evaluation will also tell funders whether the added cost of routine magnesium sulphate is justified by savings from fewer admissions and shorter stays. This is applied clinical research with a direct, near-term practical goal. Success would give emergency doctors a simple, cheap, evidence-based tool to improve outcomes for one of the most common acute respiratory emergencies.
View original technical description
This is a multicentre, pragmatic, double blind, randomised controlled trial and economic evaluation, to determine whether intravenous (IV) or nebulised magnesium sulphate should be standard first-line treatment for patients with acute severe asthma. We plan to determine whether IV or nebulised magnesium sulphate will: (1) reduce the proportion of patients who require hospital admission; and/or (2) improve patient's assessment of their breathlessness. We will recruit 1200 adults with acute severe asthma but without life-threatening features. Participants will be randomised to: 1. Intravenous magnesium sulphate, 8 mmol (2g) in 100ml normal saline given over 20 minutes and nebulised salbutamol (5mg) with 0.9% saline, given 3 times 20 minutes apart 2. Intravenous normal saline, 100ml given over 20 minutes and nebulised salbutamol (5mg) with 2 mmol (500mg) magnesium sulphate, given 3 times 20 minutes apart 3. Intravenous normal saline, 100ml given over 20 minutes and nebulised salbutamol (5mg) with 0.9% saline, given 3 times 20 minutes apart The primary outcome measures are: (1) The proportion of patients who are admitted to hospital, either after emergency department treatment or at any time over the subsequent week; and (2) The patient's visual analogue scale (VAS) for breathlessness over two hours after initiation of treatment. Secondary outcomes will include mortality, adverse events, use of ventilation or respiratory support, length of hospital stay, use of high dependency or intensive care, change in PEFR and physiological variables (oxygen saturation, heart rate, respiratory rate) over two hours, quality of life (EQ-5D) at baseline and one month, number of unscheduled health care contacts over the subsequent month, and satisfaction with care. We will also measure health care resource use (including emergency department visits, hospital admission, general practitioner and outpatient visits, tests and treatments), social care resource use and productivity losses over the subsequent month.
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