Home » Trials » SLCTR/2008/016
Efficacy of antioxidant therapy in acute paraquat poisoning
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SLCTR Registration Number
SLCTR/2008/016
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Efficacy of antioxidant therapy in acute paraquat poisoning
Public Title of Trial
Improvement following acute paraquat poisoning due to antioxidant therapy
Disease or Health Condition(s) Studied
Acute paraquat intoxication
Scientific Acronym
None
Public Acronym
None
Brief title
Antioxidant trial
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Would antioxidants (intravenous vitamin C or intravenous vitamin C to paraquat?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
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; p<0.05, from 27.0 ± 3.8 IU to 22.0 ± 2.7 IU; p<0.01 and from 99.5 ± 3.4 mmHg to 87.3 ± 7.1 mmHg ; p<0.001 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 (? 4 mg/h/kg) twice per day for 3 days The total dose will be 320 mg/kg in 72 hours
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
Primary outcome(s)
|
1.
Improvement of total antioxidant status in plasma after administration of Intra Venous vitamin C+placebo or vitamin C + NAC |
[ First five consecutive days of acute exposure to paraquat ] |
Secondary outcome(s)
|
1.
Improvement of survival |
[ Two months after acute exposure to paraquat ] |
Target number/sample size
40
Countries of recruitment
Sri Lanka
Anticipated start date
2008-08-01
Anticipated end date
2009-08-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
South Asian Clinical Toxicology Research Collaboration
Regulatory approvals
Status
Approved
Date of Approval
2008-08-19
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Sudheera Jayasinghe
Probationary Lecturer
Faculty of Medicine, University of Ruhuna
+94 91 2246877
+94 91 2222314
sudheerasj@yahoo.com
Contact Person for Public Queries
Dr Sudheera Jayasinghe
Probationary Lecturer
Faculty of Medicine, University of Ruhuna
+94 91 2246877
+94 91 2222314
sudheerasj@yahoo.com
Primary study sponsor/organization
South Asian Clinical Toxicology Research Collaboration
Faculty of Medicine, University of Peradeniya, Sri Lanka
+94 81 2384556
adawson@sactrc.com
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
