Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/07/2006
Date assigned
31/07/2006
Last edited
05/02/2015
Prospective/Retrospective
Prospectively 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 Aishath Aroona

ORCID ID

Contact details

SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
+94 (0)81 238 4556
aroona@sactrc.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

071669

Study information

Scientific title

Is magnesium an effective treatment for organophosphate poisoning?

Acronym

Study hypothesis

Is magnesium effective in reducing mortality from acute Organophosphate Poisoning (OP)?

Due to a delay to the beginning of the trial, the overall trial start date is now 03/03/2007. The overall trial end date was also therefore changed to 03/03/2009.

Ethics approval

1. Sri Lankan Medical Association Ethical Review Committee (Approval ERC/05-005), 05/08/2005.
2. Australian National University Human Ethics Research Committee (Approval 2005/195), 29/10/2005

Study design

Multicentre 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

Organophosphate poisoning

Intervention

We plan to conduct a double-blind randomised controlled trial of the effectiveness of early magnesium treatment in preventing death. Patients will be randomised to magnesium sulphate or a placebo in a 2:1 ratio. (i.e 200 patients will receive magnesium and 100 patients will receive placebo).

All patients will continue to receive standard treatment. This standard treatment is determined by the attending physician who maintains clinical responsibility for all patients. While there may be some minor variation between hospitals current care consists of patient resuscitation, gastrointestinal decontamination when indicated, atropinisation and the use of pralidoxime (typically one gram every six hours). All treatment is recorded by the research team. This intervention represents an added treatment to the existing standard of care.

Intervention type

Drug

Phase

Not Specified

Drug names

Magnesium

Primary outcome measures

The primary outcome will be the number of patients dying in those receiving magnesium versus those receiving placebo.

Secondary outcome measures

Secondary outcomes will include need for ventilation, blood pressure, level of consciousness and duration of atropine therapy. Adverse events reported by doctors will be rated by them as to the likelihood of them being due to magnesium infusion (certain, probable, possible, unlikely).

Overall trial start date

30/08/2006

Overall trial end date

03/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with symptomatic acute OP

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Patients who do not consent
2. Pregnant women
3. Patients less than 16 years of age
4. Patients who are hypotensive (blood pressure less than 90/50 mmHg) on presentation and not responding to intravenous (iv) fluids and atropine
5. Patients who have ingested other substances in addition to OP
6. Patients with other major medical conditions (e.g. cardiovascular disease renal or hepatic failure)

Recruitment start date

30/08/2006

Recruitment end date

03/03/2009

Locations

Countries of recruitment

Sri Lanka

Trial participating centre

SACTRC
Peradeniya
20000
Sri Lanka

Sponsor information

Organisation

South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)

Sponsor details

Department of Medicine
University of Peradeniya
Perideniya
20000
Sri Lanka
+94 (0)81 238 4556
adawson@sactrc.org

Sponsor type

Research organisation

Website

http://www.sactrc.org

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes