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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85372848
Enrollment
600
Registered
2006-08-01
Start date
2006-08-30
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraquat poisoning Injury, Occupational Diseases, Poisoning Paraquat poisoning

Interventions

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.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
All-cause mortality in hospital

Secondary

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

Countries

Sri Lanka

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026