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

Not Applicable

Completed

• Conditions: Paraquat poisoning; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN85372848
• Lead Sponsor: South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)

Brief Summary

2018 results in https://pubmed.ncbi.nlm.nih.gov/29098875/ (added 01/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-01
• Study Completion: 2010-12-30
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 299

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality in hospital

Secondary Outcome Measures

Name	Time	Method
<br> 1. All-cause mortality at three months post-ingestion<br> 2. Lung function in survivors at three months<br>