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

Oxford University Clinical Research Unit
Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
Q5
Viet Nam

Study information

Study designDouble blind, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymMagnesium in Tetanus
Study objectivesMagnesium 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) studiedTetanus
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Magnesium sulphate, diazepam and midazolam
Primary outcome measureRequirement for mechanical ventilation primary outcome
Secondary outcome measures1. 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 date01/05/2002
Completion date01/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants180
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2002
Date of final enrolment01/05/2005

Locations

Countries of recruitment

  • Viet Nam

Study participating centre

Oxford University Clinical Research Unit
Ho Chi Minh City
Q5
Viet Nam

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Website http://www.ox.ac.uk/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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