Improvement following acute paraquat poisoning due to antioxidant therapy

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2008/016
• Date of registration: 22/08/2008
• Primary sponsor: South Asian Clinical Toxicology Research Collaboration
• Public title: Improvement following acute paraquat poisoning due to antioxidant therapy
• Scientific title: Efficacy of antioxidant therapy in acute paraquat poisoning
• Date of first enrolment: 1/8/2008
• Target sample size: 40
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={B56916D6-C46F-4A40-B734-03EA6ED28F7B}
• Study type: Interventional
• Study design: Double blind randomize controlled trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr Sudheera Jayasinghe
• Affiliation: Probationary Lecturer

• Name: Dr Sudheera Jayasinghe
• Affiliation: Probationary Lecturer

Key inclusion & exclusion criteria

Inclusion criteria: Consecutive patients who get admitted to General Hospital, Matara following history of acute exposure to paraquat and symptoms suggestive of acute exposure to paraquat will be selected for the study
Exclusion criteria: • Unconscious patients
• Pregnant mothers

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Acute paraquat intoxication

Intervention(s)

Apart from the standard management (Fernando, 1998), patients will be given intra venous vitamin C as follow, 100 mg, 500 mg, 1000 mg, 3000 mg/day and 3000 mg/ 8 h for 5 consecutive days. S. Y. Hong et al (2002) stated that white blood cell count (WBC), serum Aspartate amino transferase (GOT) and arterial blood PaO2 were significantly decrease (from 9* 103 ± 564 mm3 to 8.5* 103 ± 347 mm3; pless than0.05, from 27.0 ± 3.8 IU to 22.0 ± 2.7 IU; pless than0.01 and from 99.5 ± 3.4 mmHg to 87.3 ± 7.1 mmHg ; pless than0.001 respectively) during the observation period after administration of Intravenous vitamin C. They also noted that when the amount of vitamin C increased to 3000 mg, patients complained pain around the injection site(Hong et al., 2002). Therefore after each dose pulse rate, blood pressure, respiratory rate, body temperature will be monitored every 6 hours and white blood cell count (WBC), liver and renal function tests, urine analysis and oxygen saturation will be conducted every day. In the treatment of paracetamol poisoning N-acetylcysteine (NAC) is given in an initial dose of 150 mg/kg in 200 ml 5% dextrose over 15 minutes followed by 50 mg/kg in 500 ml 5% dextrose over four hours and 100 mg/kg in one litre 5% dextrose over the next 16 hours (total dose 300 mg/kg in 20 hours) (Fernando, 1998; L F Prescott, 1979) But rashes and anaphylaxis are known adverse effects of N-acetylcysteine with the dose given in paracetamol poisoning. Therefore I would like to propose a regimen for NAC which can be used in paraquat intoxication. Proposed NAC regimen for paraquat intoxication will be as follow; Initially 20 mg/kg in 200mL of 5% dextrose over 15 minutes Followed by 50 mg/kg in 500mL over 12 hours (and#8776; 4 mg/h/kg) twice per day for 3 days The total dose will be 320 mg/kg in 72 hours

Primary Outcome(s)

Improvement of total antioxidant status in plasma after administration of Intra Venous vitamin C+placebo or vitamin C + NAC

Secondary Outcome(s)

Improvement of survival

Secondary ID(s)

None

Source(s) of Monetary Support

South Asian Clinical Toxicology Research Collaboration