Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
066689/z
Study information
Scientific title
Acronym
Magnesium in Tetanus
Study hypothesis
Magnesium sulphate is better than conventional treatment in controlling spasms and autonomic instability in the management of severe tetanus.
Ethics approval
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.
Study design
Double blind, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Magnesium sulphate, diazepam and midazolam
Primary outcome measures
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 trial start date
01/05/2002
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant 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%
Recruitment start date
01/05/2002
Recruitment end date
01/05/2005
Locations
Countries of recruitment
Viet Nam
Trial participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
Q5
Viet Nam
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 066689)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/pubmed/17055945
Publication citations
-
Results
Thwaites CL, Yen LM, Loan HT, Thuy TT, Thwaites GE, Stepniewska K, Soni N, White NJ, Farrar JJ, Magnesium sulphate for treatment of severe tetanus: a randomised controlled trial., Lancet, 2006, 368, 9545, 1436-1443, doi: 10.1016/S0140-6736(06)69444-0.