Magnesium sulphate in Tetanus

ISRCTN	ISRCTN74651862
DOI	https://doi.org/10.1186/ISRCTN74651862
Protocol serial number	066689/z
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 066689)

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

Primary study design	Interventional
Study design	Double blind, randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Magnesium sulphate, diazepam and midazolam
Primary outcome measure(s)	Requirement for mechanical ventilation primary outcome
Key secondary outcome measure(s)	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
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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