Magnesium sulphate for treatment of severe acute asthma
| ISRCTN | ISRCTN04417063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04417063 |
| Secondary identifying numbers | HTA 06/01/02 |
- Submission date
- 23/02/2007
- Registration date
- 26/02/2007
- Last edited
- 17/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Asthma is a common long-term condition that can cause coughing, wheezing, chest tightness and breathlessness. An asthma attack is a sudden worsening of asthma symptoms. Magnesium sulphate can be used to treat patients with a severe asthma attack. It can be given intravenously through a drip into a vein in the patient's arm, or through a nebuliser, which produces a fine spray that is then inhaled. It is currently not clear how useful magnesium sulphate is in acute severe asthma or whether it is best given intravenously or by a nebuliser. We know that magnesium improves measurements of breathing ability, but it not clear whether this results in the patient feeling better or being able to avoid hospital admission. The aim of this study to find out whether intravenous or nebulised magnesium sulphate improves the symptoms of breathlessness in patients with a severe asthma attack and/or reduces the chances of needing hospital admission.
Who can participate?
Patients aged over 16 attending the emergency department with a severe asthma attack
What does the study involve?
Participants are randomly allocated to receive either standard treatment alone, standard treatment plus intravenous magnesium sulphate, or standard treatment plus nebulised magnesium sulphate. We ask all patients to assess their breathlessness over the following two hours and then follow them up for the next month to identify any health problems. By comparing the results from the three groups of patients we can establish which treatment produces the best results. We also measure health service costs and the amount of time patients take off work to determine whether treatment with magnesium sulphate is cost-effective.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
September 2007 to September 2012
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Steve Goodacre
s.goodacre@sheffield.ac.uk
Contact information
Scientific
Health Service Research, ScHARR
The University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 0842 |
|---|---|
| s.goodacre@sheffield.ac.uk |
Study information
| Study design | Multi-centre double-blind placebo-controlled three-arm randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.shef.ac.uk/content/1/c6/07/17/87/pat_info%20v002%20May%2010%202007.doc |
| Scientific title | Magnesium sulphate for treatment of severe acute asthma |
| Study acronym | 3Mg |
| Study hypothesis | We aim to measure the effectiveness and cost-effectiveness of intravenous (IV) and nebulised magnesium sulphate in acute severe asthma and thus determine whether either should be standard first-line treatment for patients presenting to the emergency department with acute severe asthma. We plan to test the following specific hypotheses: 1. IV or nebulised magnesium sulphate will reduce the proportion of patients who require admission at initial presentation or during the following week 2. IV or nebulised magnesium sulphate will improve patients assessment of their breathlessness over two hours after initiation of treatment More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/060102 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0019/51265/PRO-06-01-02.pdf |
| Ethics approval(s) | Scotland A Research Ethics Committee, 08/06/2007 |
| Condition | Acute severe asthma in adults |
| Intervention | Current interventions as of 30/04/2008: This randomised trial will take place in up to 30 Emergency Departments in the United Kingdom. Patients will be randomised to one of three treatment arms. Each treatment arm will receive one intravenous and one nebulised treatment. The intravenous infusions and nebuliser vials will each be prepared as apparently identical solutions to ensure blinding. All three groups will also receive standard therapy, according to BTS/SIGN guidelines, with high flow oxygen and oral prednisolone. Other treatments will be given at the discretion of the attending clinician and recorded on the data collection form, although adherence to BTS/SIGN guidelines will be promoted. Patients will be managed in the emergency department and data collected until two hours after randomisation. At this point, if not already undertaken, a final disposition decision will be made (hospital admission or discharge) and initial data collection completed. Previous interventions: Patients will be randomised to one of three treatment arms. Each treatment arm will receive one intravenous and one nebulised treatment. The intravenous infusions and nebuliser vials will each be prepared as apparently identical solutions to ensure blinding. All three groups will also receive standard therapy, according to BTS/SIGN guidelines, with high flow oxygen and oral prednisolone. Other treatments will be given at the discretion of the attending clinician and recorded on the data collection form, although adherence to BTS/SIGN guidelines will be promoted. Patients will be managed in the emergency department and data collected until two hours after randomisation. At this point, if not already undertaken, a final disposition decision will be made (hospital admission or discharge) and initial data collection completed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | 1. The health service primary outcome will be the proportion of patients who are admitted to hospital, either after emergency department treatment or at any time over the subsequent week. 2. The patient-centred primary outcome will be the patients visual analogue scale (VAS) for breathlessness over two hours after initiation of treatment. |
| Secondary outcome measures | 1. Mortality 2. Adverse events 3. Use of ventilation or respiratory support 4. Length of hospital stay 5. Use of high dependency or intensive care 6. Change in PEFR and physiological variables (oxygen saturation, heart rate, respiratory rate) over two hours 7. Quality of life at baseline and one month (measured by EQ-5D) 8. Number of unscheduled health care contacts (emergency department, walk-in centre or general practitioner attendances) over the subsequent month 9. Satisfaction with care (measured by a modified Group Health Association of America survey) |
| Overall study start date | 01/09/2007 |
| Overall study end date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 between 3 trial arms (400 each) |
| Participant inclusion criteria | Current inclusion criteria as of 30/04/2008: We will recruit adults (aged greater than 16 years) admitted to the Emergency Department with acute severe asthma as defined by the British Thoracic Society (BTS) and Scottish Intercollegiate Guideline Network (SIGN) guidelines, i.e. acute asthma with either peak expiratory flow rate (PEFR) less than 50% of best or predicted, respiratory rate greater than 25/min, heart rate greater than 110/min, or inability to complete sentences in one breath. Eligible patients will be identified by medical staff and informed consent sought from the patient. Oral consent can be obtained initially, and written consent will be obtained before departure from the emergency department. Consented participants will be randomised by telephone or internet using a system developed for the Sheffield Clinical Trials Research Unit (CTRU). A simple randomisation sequence will be used to allocate participants to numbered treatment packs kept in the emergency department. Each treatment pack will contain an intravenous infusion and a nebuliser solution, either of which could be active treatment or placebo. Participants, hospital staff and research staff will all be blind to allocated treatment. Clinical staff will record baseline data, details of co-interventions and outcome data up to two hours after presentation. Further data will be collected at one month after recruitment by research nurses using routine data sources and by patient self-completion questionnaire. Previous inclusion criteria: We will recruit adults (age>16) admitted to the emergency department with acute severe asthma as defined by the British Thoracic Society (BTS) and Scottish Intercollegiate Guideline Network (SIGN) guidelines, i.e. acute asthma with either Peak Expiratory Flow Rate (PEFR) < 50% of best or predicted, respiratory rate > 25/min, heart rate > 110/min, or inability to complete sentences in one breath. Eligible patients will be identified by medical staff and written, informed consent sought from either the patient, a personal legal representative or a professional legal representative (as outlined in Medicine for Human Use (Clinical Trials) Regulations 2004). Consented participants will be randomised by telephone to the Sheffield Clinical Trials Support Unit (CTSU). A simple randomisation sequence will be used to allocate participants to numbered treatment packs kept in the emergency department. The CTSU will only reveal the allocated pack number after patient details have been recorded and the patient irreversibly entered into the trial. Each treatment pack will contain an intravenous infusion and a nebuliser solution, either of which could be active treatment or placebo. Participants, hospital staff and research staff will all be blind to allocated treatment. Clinical staff will record baseline data, details of co-interventions and outcome data up to two hours after presentation. Further data will be collected at one month after recruitment by research nurses using routine data sources and by patient self-completion questionnaire. |
| Participant exclusion criteria | Current exclusion criteria as of 30/04/2008: 1. Patients with life threatening features (oxygen saturation less than 92%, silent chest, cyanosis, poor respiratory effort, bradycardia, arrhythmia, hypotension, exhaustion, coma or confusion) 2. Patients who are unable to provide oral or written informed consent 3. Patients with a contra-indication to either nebulised or intravenous magnesium sulphate: pregnancy, hepatic or renal failure, heart block or known hypermagnesaemia 4. Previous participants in the 3Mg Trial Added 21/03/2011: 5. Patients who have received IV or nebulised magnesium sulphate in the previous 24 hours prior to admission to the emergency department. Previous exclusion criteria: 1. Patients with life threatening features (oxygen saturation < 92%, silent chest, cyanosis, poor respiratory effort, bradycardia, arrhythmia, hypotension, exhaustion, coma or confusion) 2. Patients who are unable to provide written consent and for whom no personal or professional legal representative can be identified to act on their behalf 3. Patients with a contraindication to either nebulised or intravenous magnesium sulphate: pregnancy, hepatic or renal failure, heart block or known hypermagnesaemia 4. Previous participants in the 3Mg Trial |
| Recruitment start date | 01/09/2007 |
| Recruitment end date | 30/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S1 4DA
United Kingdom
Sponsor information
Hospital/treatment centre
Brenda Zinobar
STH NHS Foundation Trust
Research Department
3rd Floor, Pegasus House
463a Glossop Road
Sheffield
S10 2QD
England
United Kingdom
| Phone | +44 (0)114 226 5938 |
|---|---|
| Brenda.Zinober@sth.nhs.uk | |
| Website | http://www.sth.nhs.uk/ |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 01/04/2014 | Yes | No |
Editorial Notes
17/05/2016: Plain English summary added.
21/03/2011: the overall trial end date was changed from 31/08/2010 to 30/09/2012.
30/04/2008: the sponsor details were updated; the previous sponsor was:
The University of Sheffield
Richard Hudson
Research Services Department
New Spring House
231 Glossop Road
Sheffield S10 2GW
United Kingdom
