Home » Trials » SLCTR/2009/001
Use of intravenous acetylsalicylic acid (‘Aspirin’) as a novel antidote for human paraquat poisoning- can it reduce the 70% mortality rate and oxidative stress?
-
SLCTR Registration Number
SLCTR/2009/001
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Use of intravenous acetylsalicylic acid (‘Aspirin’) as a novel antidote for human paraquat poisoning- can it reduce the 70% mortality rate and oxidative stress?
Public Title of Trial
Use of intravenous acetylsalicylic acid (‘Aspirin’) as a novel antidote for human paraquat poisoning- can it reduce the 70% mortality rate and oxidative stress?
Disease or Health Condition(s) Studied
Paraquat self poisoning
Scientific Acronym
Asparaquat
Public Acronym
Asparaquat
Brief title
Aspirin phase II study for paraquat
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
1.To test if concentration of markers of oxidative stress (see below) induced by paraquat can be reduced by intravenous acetylsalicylate 2.To test if acetylsalicylate can prevent death due to paraquat poisoning 3.Study the pharmacokinetics of paraquat and acetylsalicylate ?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Consenting patients will be given ASA in addition to the standard treatment. Dose of ASA will be calculated as 100mg/Kg. This will be given as an IV infusion over 1 hour. This will be followed up with an infusion of 100mg/Kg/24 hours for 72 hours. Serial plasma salicylate levels will be done and the infusion rate will be adjusted to maintain ASA levels between 200 and 350mg/L. Patients develop mild symptoms such as tinnitus at levels above 350mg/L. Patients will receive a single dose of activated charcoal or Fuller’s Earth and other supportive care. Patient’s clinical condition will be reviewed at regular intervals until death or discharge.
Inclusion criteria
Paraquat self poisoning presenting within 24 hours and a positive urine dithionite test
Exclusion criteria
Age under 14 years pregnanacy presenting after 24 hours known aspirin allergy
Primary outcome(s)
|
1.
Measure of oxidative markers as outlined before 3. Plasma and EBC 4-Hydroxy-2-nonenal and F2?-isoprostane concentrations (GC/MS) 4. Plasma and EBC proteins CC16 and SP-D (Assay kits) 5. EBC Hydrogen peroxide concentrations (Assay kit) 6. EBC Thiobarbituric Acid Reactive Substances (TBARS) (spectrophotometric assay) 7. EBC Proteomic 8. Urinary F2?-isoprostane and prostacyclin levels |
[] |
Secondary outcome(s)
|
1.
Death |
[] |
Target number/sample size
20
Countries of recruitment
Sri Lanka
Anticipated start date
2009-03-02
Anticipated end date
2010-01-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Welcome Trust and NHMRC
Regulatory approvals
Status
Approved
Date of Approval
2008-03-25
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Indika Gawarammana
Senior Lecturer and Consultant Physician
Department of Clinical Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka
0094714225081
0094814479822
indika@sactrc.org
Contact Person for Public Queries
Indika Gawarammana
Senior Lecturer and Consultant Physician
Department of Clinical Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka
0094714225081
0094814479822
indika@sactrc.org
Primary study sponsor/organization
Welcome Trust and NHMRC through SACTRC
Faculty of Medicine, University of Peradeniya, Sri Lanka
0094814479822
0094814479822
contact@sactrc.org
www.sactrc.org
Secondary study sponsor (If any)
SACTRC
Faculty of Medicine, University of Peradeniya, Sri Lanka
0094814479822
contact@sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
