Use of intravenous acetylsalicylic acid (‘Aspirin’) as a novel antidote for human paraquat poisoning- can it reduce the 70% mortality rate and oxidative stress?

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2009/001
• Date of registration: 16/01/2009
• Primary sponsor: Welcome Trust and NHMRC through SACTRC
• Public title: Use of intravenous acetylsalicylic acid (‘Aspirin’) as a novel antidote for human paraquat poisoning- can it reduce the 70% mortality rate and oxidative stress?
• Scientific title: Use of intravenous acetylsalicylic acid (‘Aspirin’) as a novel antidote for human paraquat poisoning- can it reduce the 70% mortality rate and oxidative stress?
• Date of first enrolment: 2/3/2009
• Target sample size: 20
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={75AA3EDD-DBAE-4B2C-ABA6-319C32C6AACA}
• Study type: Interventional
• Study design: Phase II study

Countries of recruitment

Sri Lanka

Contacts

• Name: Indika Gawarammana
• Affiliation: senior Lecturer

• Name: Indika gawarammana
• Affiliation: Senior Lecturer and Consultant Physician

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Paraquat self poisoning

Intervention(s)

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.

Primary Outcome(s)

Measure of oxidative markers as outlined before
3. Plasma and EBC 4-Hydroxy-2-nonenal and F2and#945;-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 F2and#945;-isoprostane and prostacyclin levels

Secondary ID(s)

Sal02.06.2008

Source(s) of Monetary Support

Welcome Trust and NHMRC

Secondary Sponsor(s)

SACTRC