A randomised controlled trial of high-dose immunosuppression in paraquat poisoning

ISRCTN	ISRCTN85372848
DOI	https://doi.org/10.1186/ISRCTN85372848
Secondary identifying numbers	071669

Submission date: 31/07/2006
Registration date: 01/08/2006
Last edited: 01/07/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Pilane Liyanage Ariyananda
Scientific

SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka

Phone	+94 (0)81 238 4556
Email	ariyananda@sltnet.lk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A randomised controlled trial of high-dose immunosuppression in paraquat poisoning
Study objectives	To assess whether intravenous cyclophosphamide and methylprednisolone, followed by dexamethasone, as supplementary therapy to a single dose of fullers 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(s)	The Ethics Committee of the Faculty of Medicine, University of Ruhana gave approval on the 18th April 2006
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Cyclophosphamide, methylprednisone, dexamethasone, fuller's earth or activated charcoal
Primary outcome measure	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 study start date	30/08/2006
Completion date	30/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600 (300 active, 300 placebo)
Total final enrolment	299
Key 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
Key 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
Date of first enrolment	30/08/2006
Date of final enrolment	30/12/2010

Locations

Countries of recruitment

Sri Lanka

Study participating centre

SACTRC

Peradeniya
20000
Sri Lanka

Sponsor information

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

Department of Medicine
University of Peradeniya
Perideniya
20000
Sri Lanka

Phone	+94 (0)81 238 4556
Email	adawson@sactrc.org
Website	http://www.sactrc.org
"ROR"	https://ror.org/04z435g27

Funders

Funder type

Industry

Syngenta Crop Protection AG (USA)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/07/2018	01/07/2021	Yes	No

Editorial Notes

01/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.