Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/07/2006
Date assigned
01/08/2006
Last edited
15/01/2009
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

Mr Pilane Liyanage Ariyananda

ORCID ID

Contact details

SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
+94 (0)81 238 4556
ariyananda@sltnet.lk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

071669

Study information

Scientific title

Acronym

Study hypothesis

To assess whether intravenous cyclophosphamide and methylprednisolone, followed by dexamethasone, as supplementary therapy to a single dose of fuller’s earth or activated charcoal, prevents death from paraquat-induced lung fibrosis.

Please note that as of 15/01/2009 this record was updated to include an extended anticipated end date of 30/12/2010. The initial anticipated end date of this trial was 30/12/2008.

Ethics approval

The Ethics Committee of the Faculty of Medicine, University of Ruhana gave approval on the 18th April 2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Paraquat poisoning

Intervention

Two days of cyclophosphamide 750 mg (if weight is less than 50 kg) or one gram (if weight is more than 50 kg), and three days of methylprednisolone one gram both by intravenous infusion over one hour. Steroids in the form of oral dexamethasone (8 mg three times daily) will be continued for the next two weeks. Patients will receive mesna 400 mg intravenous at start of therapy and four and eight hours later to reduce risk of haemorrhagic cystitis.

Control patients will receive saline placebo infusion and placebo capsules.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cyclophosphamide, methylprednisone, dexamethasone, fuller's earth or activated charcoal

Primary outcome measures

All-cause mortality in hospital

Secondary outcome measures

1. All-cause mortality at three months post-ingestion
2. Lung function in survivors at three months

Overall trial start date

30/08/2006

Overall trial end date

30/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a history of acute paraquat poisoning
2. Presenting within 24 hours of paraquat ingestion with evidence of paraquat intoxication by urinary dithionite test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600 (300 active, 300 placebo)

Participant exclusion criteria

1. Under 14 years
2. Pregnant
3. Systolic blood pressure of less than 70 mmHg, unresponsive to one litre fluid challenge, Glasgow Coma Score (GCS) less than 8/15, or cyanosis
4. Already received cyclophosphamide or methylprednisolone for this episode of poisoning
5. Allergic to cyclophosphamide, methylprednisolone, dexamethasone or mesna
6. Unable to give consent, or not accompanied by a relative, where the hospital consultant prefers that consent be obtained from a relative rather than the consultant looking after the patient
7. Present more than 24 hours after paraquat ingestion

Recruitment start date

30/08/2006

Recruitment end date

30/12/2010

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

Industry

Funder name

Syngenta Crop Protection AG (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant ref: 071669)

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

Publication citations

Additional files

Editorial Notes