A randomised controlled trial of high-dose immunosuppression in paraquat poisoning
| ISRCTN | ISRCTN85372848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85372848 |
| Protocol serial number | 071669 |
| Sponsor | South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka) |
| Funders | Syngenta Crop Protection AG (USA), The Wellcome Trust (UK) (grant ref: 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
Scientific
SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
| Phone | +94 (0)81 238 4556 |
|---|---|
| ariyananda@sltnet.lk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, methylprednisone, dexamethasone, fuller's earth or activated charcoal |
| Primary outcome measure(s) |
All-cause mortality in hospital |
| Key secondary outcome measure(s) |
1. All-cause mortality at three months post-ingestion |
| Completion date | 30/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 600 |
| 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
20000
Sri Lanka
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
