Condition category
Infections and Infestations
Date applied
27/08/2006
Date assigned
05/09/2006
Last edited
11/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catherine Thwaites

ORCID ID

Contact details

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

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

http://www.ox.ac.uk/

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

  1. 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.

Additional files

Editorial Notes