Magnesium sulphate in Tetanus
| ISRCTN | ISRCTN74651862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74651862 |
| Secondary identifying numbers | 066689/z |
- Submission date
- 27/08/2006
- Registration date
- 05/09/2006
- Last edited
- 11/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Catherine Thwaites
Scientific
Scientific
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
Q5
Viet Nam
Study information
| Study design | Double blind, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Magnesium in Tetanus |
| Study objectives | Magnesium sulphate is better than conventional treatment in controlling spasms and autonomic instability in the management of severe tetanus. |
| Ethics approval(s) | OXTREC (Oxford University Tropical Research Ethical Committee) approval gained for study in March 2002 (reference number: 003-02) and Hospital for Tropical Diseases Scientific and Ethical Committee, Ho Chi Minh City, Viet Nam, approved of study in March 2002. |
| Health condition(s) or problem(s) studied | Tetanus |
| Intervention | Group one - intervention group: Magnesium Sulphate intravenous (iv) infusion 0.5 - 2 g/hr. Group two - control group: Conventional treatment of intravenous diazepam (bolus 5 - 10 mg) or midazolam (infusion 1 - 10 mg/hr), but if spasms were not controlled intravenous infusions of pipecuronium were given. Autonomic distrubance was treated with verapamil, morphine or digoxin. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate, diazepam and midazolam |
| Primary outcome measure | Requirement for mechanical ventilation primary outcome |
| Secondary outcome measures | 1. Requirement for benzodiazepines, pipecuronium, morphine and verapamil (mg/kg) 2. Hourly Systolic Blood Pressure (SBP) and Heart Rate (HR) recording and mean seven day maximum SBP, HR and daily variation in SBP 3. In hospital mortality (including patients taken home to die) 4. Length of Intensive Care Unit (ICU) stay, total hospital stay and total cost of hospital stay 5. Requirement for ventilation during hospital stay 6. Daily 8 am serum Creatinine Kinase (CK) measurement 7. Urinary epinephrine and norepinephrine, measured from a 24 hour collection on day two of the study |
| Overall study start date | 01/05/2002 |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 |
| Key inclusion criteria | 1. Adults with Ablett classification of tetanus severity grade three or four 2. Patient over 15 years with diagnosed tetanus 3. Tracheostomy more than six hours and not yet ventilated |
| Key exclusion criteria | 1. Urine output less than 1 ml/kg/hr 2. Electrocardiogram (ECG) evidence of conduction abnormalities/ischaemia 3. Serum creatinine more than 1.5 mg% |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
Q5
Viet Nam
Q5
Viet Nam
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 066689)
No information available
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 | 21/10/2006 | Yes | No |
